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FDA approves first cancer drug Kisqali (ribociclib) through new oncology review pilot that enables greater development efficiency FDA expands the use of breast cancer drug
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency FDA expands the use of breast cancer drug
The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved Kisqali in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.
July 18, 2018
Release
The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved Kisqali in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.
This is the first approval that FDA has granted as a part of two new pilot programs announced earlier this year that collectively aim to make the development and review of cancer drugs more efficient, while improving FDA’s rigorous standard for evaluating efficacy and safety. With this real-time review, the FDA was able to start evaluating the clinical data as soon as the trial results become available, enabling FDA to be ready to approve the new indication upon filing of a formal application with the Agency.
The first new program, called Real-Time Oncology Review, allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked, before the information is formally submitted to the FDA. This allows the FDA to begin its analysis of the data earlier, and provide feedback to the sponsor on how they can most effectively analyze the data to answer key regulatory questions. The pilot focuses on early submission of data that are the most relevant to assessing safety and effectiveness of the product. Then, when the sponsor submits the application with the FDA, the review team will already be familiar with the data and in a better position to conduct a more efficient, timely, and thorough review.
The second program is a new templated Assessment Aid that the applicant uses to organize its submission into a structured format to facilitate FDA’s review of the application. By using a structured template, the FDA is able to layer its assessment into the same file submitted by the sponsor, allowing this annotated application to serve as the document that contains the FDA review. This voluntary submission form provides for a more streamlined approach to reviewing data and illustrating FDA’s analysis. It allows for drug reviewers to focus on the key benefit-risk and labeling issues rather than administrative issues.
“With this approval, we’ve demonstrated some of the benefits of the new programs that we’re piloting for our review of cancer drugs, to improve regulatory efficiency while enhancing the process for evaluating the data submitted to us. This shows that, with smart policy approaches, we can gain efficiency while also improving the rigor of our process. These new programs were designed to reduce some of the administrative issues that can add to the time and cost of the review process, including the staffing burdens on the FDA. For example, by analyzing data earlier in the process, before formal submission to the FDA, and evaluating submissions in a structured template, we can make it easier to identify earlier when applications are missing key analysis or information that can delay reviews,” said FDA Commissioner Scott Gottlieb, M.D. “With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information. This enabled our approval less than one month after the June 28 submission date and several months ahead of the goal date.”
These new processes are good for patients, good for health care providers, good for product developers, and good for the FDA, by allowing our staff to have more time to engage with product developers and focus on the key aspects of drug reviews. We can improve efficiency and solidify our gold standard for review.”
Currently the two pilot programs are being used for supplemental applications for already-approved cancer drugs and could later be expanded to original drugs and biologics.
Kisqali was first approved in March 2017 for use with an AI to treat HR-positive, HER2-negative breast cancer in post-menopausal women whose cancer is advanced or has spread to other parts of the body.
“The approval adds a new treatment choice for patients with breast cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to continuing to bring more treatment options to patients.”
Breast cancer is the most common form of cancer in the United States. The National Cancer Institute at the National Institutes of Health estimates approximately 266,120 women will be diagnosed with breast cancer this year and 40,920 will die of the disease. Approximately 72 percent of patients with breast cancer have tumors that are HR-positive and HER2-negative.
The efficacy of Kisqali in combination with an AI for pre/perimenopausal women was demonstrated in a clinical trial of 495 participants who received either Kisqali and an AI or placebo and an AI. All pre- or peri-menopausal patients on this study received ovarian suppression with goserelin. The trial measured progression-free survival (PFS), which is generally the amount of time after the start of this treatment during which the cancer does not substantially grow and the patient is alive. PFS was longer for patients taking Kisqali plus an AI (median PFS of 27.5 months) compared to patients who received placebo plus an AI (median PFS of 13.8 months).
The efficacy of Kisqali in combination with fulvestrant in treating advanced or metastatic breast cancer was demonstrated in a clinical trial that included 726 participants who received either Kisqali and fulvestrant or placebo and fulvestrant. The trial measured PFS, which was longer for patients taking Kisqali plus fulvestrant (median PFS of 20.5 months) compared to patients who received placebo plus fulvestrant (median PFS of 12.8 months).
The common side effects of Kisqali are infections, abnormally low count of a type of white blood cell (neutropenia), a reduction in the number of white cells in the blood (leukopenia), headache, cough, nausea, fatigue, diarrhea, vomiting, constipation, hair loss and rash.
Warnings include the risk of a heart problem known as QT prolongation that can cause an abnormal heartbeat and may lead to death, serious liver problems, low white blood cell counts that may result in infections that may be severe, and fetal harm.
The FDA granted Priority Review and Breakthrough Therapy designation for this indication.
The FDA granted this approval to Novartis Pharmaceuticals Corporation.
Novel Drug Approvals for 2017, A Review/Compilation
CDSCO
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO, Novel Drug Approvals for 2017, A Review Compilation (USFDA, EMA, PMDA, CDSCO).
Any errors in this compilation, email amcrasto@gmail.com, Call +919323115463
Some gaps will be filled up soon keep watching……………..
INDEX, NAME (click on the title, it contains link)
SECTION A; USFDA Approvals
6 BENRALIZUMAB
17 DURVALUMAB
24 GUSELKUMAB
36 OZENOXACIN
40 SARILUMAB
41 SECNIDAZOLE
INDEX, FORMULATION NAME
USFDA
•Aliqopa (COPANLISIB) to treat adults with relapsed follicular lymphoma — a slow-growing type of nonHodgkin lymphoma (a cancer of the lymph system) — who have received at least two prior systemic therapies;
• ALUNBRIG, BRIGATINIB, To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
• Austedo, Deutetrabenazine For the treatment of chorea associated with Huntington’s disease
• Bavencio (avelumab) for the treatment of patients 12 years and older with a rare and aggressive form of cancer called metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy;
•BAXDELLA, Delafloxacin, BACTERIAL INFECTIONS
• Benznidazole to treat children ages 2 to 12 years with Chagas disease, a parasitic infection that can cause serious heart illness after years of infection, and can also affect swallowing and digestion. This is the first treatment approved in the United States for this rare disease;
• Besponsa (inotuzumab ozogamicin) for the treatment of adults with a type of cancer of the blood called relapsed or refractory B-cell precursor acute lymphoblastic leukemia;
•BEVYXXA, BETRIXABAN, For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness
• BRINEURA, CERLIPONASE ALFA, To treat a specific form of Batten disease
• Calquence (ACALABRUTINIB) to treat adults with mantle cell lymphoma who have received at least one prior therapy. Mantle cell lymphoma is a particularly aggressive cancer;
• DUPIXENT, (DUPILUMAB) To treat adults with moderate-to-severe eczema (atopic dermatitis)
• Emflaza (deflazacort) to treat patients age 5 years and older with Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle deterioration and weakness;
• FASENRA, BENRALIZUMAB, For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
• Giapreza (angiotensin II), for the treatment of hypotension in adults with distributive or vasodilatory shock (dangerously low blood pressure despite adequate heart function) whose blood pressure remains low despite receiving fluids and treatment with drugs called vasopressors;
• HEMLIBRA EMICIZUMAB To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
• Idhifa (enasidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia, a form of blood cancer, who have a specific genetic mutation;
• IMFINZI, DURVALUMAB To treat patients with locally advanced or metastatic urothelial carcinoma
• Ingrezza (valbenazine) to treat adults with tardive dyskinesia, a side effect of some antipsychotic medications whereby patients can experience uncontrollable stiff, jerky movements of their face and body, and other uncontrolled movements such as eye-blinking, sticking out the tongue, and arm-waving;
• KEVZARA SARILUMAB, RHEUMATOID ARTHRITIS
• KISQALI, RIBOCICLIB, To treat postmenopausal women with a type of advanced breast cancer
• Macrilen macimorelin acetate, For the diagnosis of adult growth hormone deficiency
• Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease, as well as those who are on hemodialysis;
• Mepsevii (vestronidase alfa-vjbk) to treat patients with Sly syndrome or mucopolysaccharidosis type 7 – a rare genetic disorder where an enzyme deficiency results in skeletal abnormalities, developmental delay, enlarged liver and spleen, and narrowed airways, which can lead to respiratory infections;
• Nerlynx (neratinib) for the extended adjuvant treatment — a form of therapy administered after an initial treatment to further lower the risk of the cancer coming back — of early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer;
• OCREVUS, OCRELIZUMAB, To treat patients with relapsing and primary progressive forms of multiple sclerosis
• OZEMPIC SEMAGLUTIDE To improve glycemic control in adults with type 2 diabetes mellitus
•PARSABIV, ETELCALCETIDE, To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
• Prevymis (letermovir) for prevention of an infection called cytomegalovirus (CMV) in patients who are receiving a bone marrow transplant. CMV disease can cause serious health issues in these patients;
• Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig’s disease, a rare disease that attacks and kills the nerve cells that control voluntary muscles;
• RHOPRESSA, NETARSUDIL, To treat glaucoma or ocular hypertension
• Rydapt (midostaurin) to treat adults newly diagnosed with a form of blood cancer known as acute myeloid leukemia who have a specific genetic mutation called FLT3, in combination with chemotherapy;
• Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis, a chronic disorder in which the body’s immune system sends out faulty signals that speed growth of skin cells that then accumulate, causing red, flaky patches that can appear anywhere on the body;
•SOLOSEC, SECNIDAZOLE To treat bacterial vaginosis
• STEGLATRO ERTUGLIFLOZIN To improve glycemic control in adults with type 2 diabetes mellitus
• Symproic (Naldemedine) for the treatment of opioid-induced constipation in adults with chronic noncancer pain; • Tremfya (guselkumab) for the treatment of adults with moderate-to-severe plaque psoriasis;
• Trulance (plecanatide) to treat adults with chronic idiopathic constipation, which is a persistent condition of constipation due to unknown origin;
• TYMLOS, Abaloparatide, To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
• Vabomere (vaborbactam and meropenem) for treatment of adults with complicated urinary tract infections, including pyelonephritis (kidney infection) caused by bacteria;
• Verzenio (abemaciclib) to treat adults who have hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy);
• Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis;
• Xadago (safinamide) as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes;
• XERMELO, TELOTRISTAT ETHYL combined with somatostatin analog (SSA) therapy to treat adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled, and;
• XEPI OZENOXACIN TO TREAT IMPETIGO
•XERMELO, TELOTRISTAT ETHYL, To treat carcinoid syndrome diarrhea
• Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy
USFDA
No. | Drug Name |
Active Ingredient | Approval Date | FDA-approved use on approval date |
---|---|---|---|---|
46. | Giapreza | angiotensin II | 12/21/2017 | To increase blood pressure in adults with septic or other distributive shock |
45. | Macrilen | macimorelin acetate | 12/20/2017 | For the diagnosis of adult growth hormone deficiency |
44. | Steglatro | ertugliflozin | 12/19/2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
43. | Rhopressa | netarsudil | 12/18/2017 | To treat glaucoma or ocular hypertension |
42. | Xepi | ozenoxacin | 12/11/2017 | To treat impetigo Drug Trials Snapshot |
41. | Ozempic | semaglutide | 12/5/2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
40. | Hemlibra | emicizumab | 11/16/2017 | To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. |
39. | Mepsevii | vestronidase alfa-vjbk | 11/15/2017 | To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. |
38. | Fasenra | benralizumab | 11/14/2017 | For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Drug Trials Snapshot |
37. | Prevymis | letermovir | 11/8/2017 | To prevent infection after bone marrow transplant Drug Trials Snapshot |
36. | Vyzulta | latanoprostene bunod ophthalmic solution | 11/2/2017 | To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Drug Trials Snapshot |
35. | Calquence | acalabrutinib | 10/31/2017 | To treat adults with mantle cell lymphoma Press Release Drug Trials Snapshot |
34. | Verzenio | abemaciclib | 9/28/2017 | To treat certain advanced or metastatic breast cancers Press Release Drug Trials Snapshot |
33. | Solosec | secnidazole | 9/15/2017 | To treat bacterial vaginosis Drug Trials Snapshot |
32. | Aliqopa | copanlisib | 9/14/2017 | To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot |
31. | benznidazole | benznidazole | 8/29/2017 | To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot |
30. | Vabomere | meropenem and vaborbactam | 8/29/2017 | To treat adults with complicated urinary tract infections Press Release Drug Trials Snapshot |
29. | Besponsa | inotuzumab ozogamicin | 8/17/2017 | To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot |
28. | Mavyret | glecaprevir and pibrentasvir | 8/3/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
27. | Idhifa | enasidenib | 8/1/2017 | To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot |
26. | Vosevi | sofosbuvir, velpatasvir and voxilaprevir | 7/18/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
25. | Nerlynx | neratinib maleate | 7/17/2017 | To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot |
24. | Tremfya | guselkumab | 7/13/2017 | For the treatment of adult patients with moderate-to-severe plaque psoriasis Drug Trials Snapshot |
23. | Bevyxxa | betrixaban | 6/23/2017 | For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot |
22. | Baxdela | delafloxacin | 6/19/2017 | To treat patients with acute bacterial skin infections Drug Trials Snapshot |
21. | Kevzara | sarilumab | 5/22/2017 | To treat adult rheumatoid arthritis Drug Trials Snapshot |
20. | Radicava | edaravone | 5/5/2017 | To treat patients with amyotrophic lateral sclerosis (ALS) Press Release Drug Trials Snapshot |
19. | Imfinzi | durvalumab | 5/1/2017 | To treat patients with locally advanced or metastatic urothelial carcinoma Web Post Drug Trials Snapshot |
18. | Tymlos | abaloparatide | 4/28/2017 | To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies Drug Trials Snapshot |
17. | Rydapt | midostaurin | 4/28/2017 | To treat acute myeloid leukemia Press Release Chemistry Review(s) (PDF) Drug Trials Snapshot |
16. | Alunbrig | brigatinib | 4/28/2017 | To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot |
15. | Brineura | cerliponase alfa | 4/27/2017 | To treat a specific form of Batten disease Press Release Drug Trials Snapshot |
14. | Ingrezza | valbenazine | 4/11/2017 | To treat adults with tardive dyskinesia Press Release Chemistry Review(s) (PDF)Drug Trials Snapshot |
13. | Austedo | deutetrabenazine | 4/3/2017 | For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot, Chemistry Review(s) (PDF) |
12. | Ocrevus | ocrelizumab | 3/28/2017 | To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot |
11. | Dupixent | dupilumab | 3/28/2017 | To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot |
10. | Zejula | niraparib | 3/27/2017 | For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot |
9. | Symproic | naldemedine | 3/23/2017 |
For the treatment of opioid-induced constipation |
8. | Bavencio | avelumab | 3/23/2017 | To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot |
7. | Xadago | safinamide | 3/21/2017 | To treat Parkinson’s disease Press Release Drug Trials SnapshotChemistry Review(s) (PDF) |
6. | Kisqali | ribociclib | 3/13/2017 | To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot |
5. | Xermelo | telotristat ethyl | 2/28/2017 | To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot |
4. | Siliq | brodalumab | 2/15/2017 | To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot |
3. | Emflaza | deflazacort | 2/9/2017 | To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot |
2. | Parsabiv | etelcalcetide | 2/7/2017 | To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials Snapshot |
1. | Trulance | plecanatide | 1/19/2017 | To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot |
* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.
USFDA 2017 | ||||||
2017/12/21 | Angiotensin II | Giapreza | La Jolla Pharmaceutical | |||
2017/12/20 | Ertugliflozin | Steglatro | Merck Sharp Dohme | |||
2017/12/20 | Macimorelin acetate | Macrilen | Aeterna Zentaris GmbH | |||
2017/12/18 | Netarsudil mesylate | Rhopressa | Aerie Pharmaceuticals | |||
2017/12/11 | Ozenoxacin | Xepi | Ferrer Internacional S.A. | |||
2017/12/5 | Semaglutide | Ozempic | Novo Nordisk Inc | |||
2017/11/16 | Emicizumab | Hemlibra | Genentech | BLA | ||
2017/11/15 | Vestronidase alfa | Mepsevii | Ultragenyx Pharmaceutical | BLA | ||
2017/11/14 | Benralizumab | Fasenra | AstraZeneca AB | BLA | ||
2017/11/8 | Letermovir | Prevymis | Merck Sharp Dohme | |||
2017/11/2 | Latanoprostene bunod | Vyzulta | Bausch & Lomb Incorporated | |||
2017/10/31 | Acalabrutinib | Calquence | AstraZeneca Pharmaceuticals LP | |||
2017/9/28 | Abemaciclib | Verzenio | Eli Lilly | |||
2017/9/15 | Secnidazole | Solosec | Symbiomix Therapeutics | |||
2017/9/14 | Copanlisib | Aliqopa | Bayer Healthcare Pharmaceuticals | |||
2017/8/29 | Benznidazole | Chemo Research | ||||
2017/8/29 | Meropenem – Vaborbactam | Vabomere | Rempex Pharmaceuticals | |||
2017/8/17 | Inotuzumab ozogamicin | Besponsa | Wyeth Pharmaceuticals | BLA | ||
2017/8/3 | Glecaprevir – Pibrentasvir | Mavyret | AbbVie | |||
2017/8/1 | Enasidenib | Idhifa | Celgene Corporation | |||
2017/7/18 | Sofosbuvir – Velpatasvir – Voxilaprevir | Vosevi | Gilead Sciences | |||
2017/7/17 | Neratinib maleate | Nerlynx | Puma Biotechnology | |||
2017/7/13 | Guselkumab | Tremfya | Janssen Biotech | BLA | ||
2017/6/23 | Betrixaban | Bevyxxa | Portola Pharmaceuticals | |||
2017/6/19 | Delafloxacin meglumine | Baxdela | Melinta Therapeutics | |||
2017/5/22 | Sarilumab | Kevzara | Sanofi Synthelabo | BLA | ||
2017/5/5 | Edaravone | Radicava | Mitsubishi Tanabe Pharma America | |||
2017/5/1 | Durvalumab | Imfinzi | AstraZeneca UK | BLA | ||
2017/4/28 | Abaloparatide | Tymlos | Radius Health | |||
2017/4/28 | Midostaurin | Rydapt | Novartis Pharmaceuticals | |||
2017/4/28 | Brigatinib | Alunbrig | Ariad Pharmaceuticals | |||
2017/4/27 | Cerliponase alfa | Brineura | BioMarin Pharmaceutical | BLA | ||
2017/4/11 | Valbenazine | Ingrezza | Neurocrine Biosciences | |||
2017/4/3 | Deutetrabenazine | Austedo | Teva Pharmaceuticals | |||
2017/3/28 | Ocrelizumab | Ocrevus | Genentech | BLA | ||
2017/3/28 | Dupilumab | Dupixent | Regeneron Pharmaceuticals | BLA | ||
2017/3/27 | Niraparib | Zejula | Tesaro | |||
2017/3/23 | Naldemedine tosylate | Symproic | Shionogi | |||
2017/3/23 | Avelumab | Bavencio | EMD Serono | BLA | ||
2017/3/23 | Safinamide mesylate | Xadago | Newron Pharmaceuticals | |||
2017/3/21 | Ribociclib | Kisqali | Novartis Pharmaceuticals | |||
2017/2/28 | Telotristat ethyl | Xermelo | Lexicon Pharmaceuticals | |||
2017/2/15 | Brodalumab | Siliq | Valeant Pharmaceuticals | BLA | ||
2017/2/9 | Deflazacort | Emflaza | Marathon Pharmaceuticals | |||
2017/2/8 | Etelcalcetide hydrochloride | Parsavib | KAI Pharmaceuticals | |||
2017/1/19 | Plecanatide | Trulance | Synergy Pharmaceuticals |
1 Abaloparatide
RADIUS
FDA 4/28/2017
To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
Drug Trials Snapshot
2 Abemaciclib
ELI LILLY
Verzenio | abemaciclib | FDA 9/28/2017 | To treat certain advanced or metastatic breast cancers Press Release Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2015/10/19/abemaciclib-bemaciclib/
3 Acalabrutinib
Calquence | FDA APPROVED
10/31/2017 |
To treat adults with mantle cell lymphoma Press Release Drug Trials Snapshot |
4 Angiotensin II
LA JOLLA
Giapreza | angiotensin II | 12/21/2017 | To increase blood pressure in adults with septic or other distributive shock Press Release Drug Trials Snapshot |
5 AVELUMAB
MERCK
Bavencio | FDA 3/23/2017 | To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot |
6 BENRALIZUMAB
ASTRA ZENECA
Fasenra benralizumab
FDA 11/14/2017
For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
Drug Trials Snapshot
7 Benznidazole
CHEMO RESEARCH
benznidazole | FDA
8/29/2017 |
To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot |
8 BETRIXABAN
PORTOLA PHARMA
Bevyxxa | FDA
6/23/2017 |
For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot
|
9 BRIGATINIB
TAKEDA
Alunbrig | FDA
4/28/2017 |
To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot |
10 BRODALUMAB
VALEANT PHARMA
Siliq | FDA
2/15/2017 |
To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot |
LINK ,,,,https://newdrugapprovals.org/2017/02/16/fda-approves-new-psoriasis-drug-siliq-brodalumab/
11 CERLIPONASE ALFA
Brineura | FDA 4/27/2017 | To treat a specific form of Batten disease Press Release Drug Trials Snapshot |
12 Copanlisib
Aliqopa | FDA APPROVED
9/14/2017 |
To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot |
LINK…..https://newdrugapprovals.org/2017/11/20/copanlisib/
13 DEFLAZACORT
MARATHON PHARMA
Emflaza | FDA 2/9/2017 | To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot |
LINK……https://newdrugapprovals.org/2017/02/17/deflazacort/
14 DELAFLOXACIN
Baxdela | FDA APPROVED
6/19/2017 |
To treat patients with acute bacterial skin infections |
LINK……..https://newdrugapprovals.org/2018/01/25/delafloxacin/
15 Deutetrabenazine
TEVA
LINK……………https://newdrugapprovals.org/2015/08/15/sd-809-deutetrabenazine-nda-submitted-by-teva/
Austedo | FDA 4/3/2017 | For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot Chemistry Review(s) (PDF) |
16 DUPILUMAB
SANOFI/REGENERON
Dupixent | FDA | 3/28/2017 | To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot |
LINK…….https://newdrugapprovals.org/2017/03/29/fda-approves-new-eczema-drug-dupixent-dupilumab/
17 DURVALUMAB
ASTRA ZENECA
durvalumab FDA 5/1/2017To treat patients with locally advanced or metastatic urothelial carcinoma
Web Post
Drug Trials Snapshot
18 EDAVARONE
MITSUBISHI TANABE
Radicava | FDA 5/5/2017 | To treat patients with amyotrophic lateral sclerosis (ALS) Press Release Drug Trials Snapshot |
19 EMICIZUMAB
ROCHE
Hemlibra | emicizumab | FDA 11/16/2017 | To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. Press Release Drug Trials Snapshot |
20 Enasidenib
Idhifa | FDA
8/1/2017 |
To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot |
21 Ertugliflozin
MERCK
Steglatro | ertugliflozin | FDA
12/19/2017 |
To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2014/02/10/ertugliflozin/
22 ETELCALCETIDE
Amgen
Parsabiv | FDA APPROVED
2/7/2017 |
To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials SnapshotSYNTHESIS LINK……..https://cen.acs.org/articles/96/i4/the-year-in-new-drugs-2018.html |
SYNTHESIS LINK……..https://cen.acs.org/articles/96/i4/the-year-in-new-drugs-2018.html
23 GLECAPREVIR
ABBVIE
Mavyret | glecaprevir and pibrentasvir | FDA 8/3/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2016/10/05/glecaprevir-abt-493/
24 GUSELKUMAB
JOHNSON AND JOHNSON
guselkumab
FDA 7/13/2017
For the treatment of adult patients with moderate-to-severe plaque psoriasis
Drug Trials Snapshot
25 Inotuzumab ozogamicin
PFIZER
Besponsa | FDA
8/17/2017 |
To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot |
26 LATANOPROSTENE
VALEANT
latanoprostene bunod ophthalmic solution
FDA 11/2/2017
To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Drug Trials Snapshot
27 LETERMOVIR
MERCK
Prevymis | FDA 11/8/2017 | To prevent infection after bone marrow transplant Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2016/05/16/letermovir-aic-246/
28 Macimorelin acetate
AETERNA ZENTARIS
Macrilen | macimorelin acetate | FDA
12/20/2017 |
For the diagnosis of adult growth hormone deficiency Drug Trials Snapshot |
29 MEROPENEM
30 MIDOSTAURIN
NOVARTIS
- Chemistry Review(s) (PDF)
Rydapt | FDA
4/28/2017 |
To treat acute myeloid leukemia Press Release Drug Trials Snapshot |
31 Naldemedine
FDA 3/23/2017, Symproic, For the treatment of opioid-induced constipation
32 NERATINIB MALEATE
PUMA BIOTECH
Nerlynx | FDA | 7/17/2017 | To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot |
33 NETARSUDIL
Rhopressa | FDA APPROVED
12/18/2017 |
To treat glaucoma or ocular hypertension |
LINK……https://newdrugapprovals.org/2018/01/29/netarsudil/
34 NIRAPARIB
TESARO
Zejula | FDA | 3/27/2017 | For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot |
LINK…https://newdrugapprovals.org/2016/12/22/niraparib-mk-4827/
35 OCRELIZUMAB
ROCHE
Ocrevus | FDA | 3/28/2017 | To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot |
36 OZENOXACIN
MEDIMETRIX
Xepi | ozenoxacin | FDA
12/11/2017 |
To treat impetigo Drug Trials Snapshot |
37 Pibrentasvir
ABBVIE
Mavyret | glecaprevir and pibrentasvir | FDA 8/3/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2016/06/08/abt-530-pibrentasvir/
38 PLECANATIDE
Plecanatide 普卡那肽 ليكاناتيد плеканатид
SYNERGY PHARMA
Trulance | FDA APPROVED
1/19/2017 |
To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot |
39 RIBOCICLIB
NOVARTIS
Structure..link for correct structure
Kisqali | FDA 3/13/2017 | To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2015/10/19/ribociclib/
40 SARILUMAB
SANOFI /REGENERON
Kevzara | sarilumab | FDA 5/22/2017 | To treat adult rheumatoid arthritis Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2013/11/25/late-stage-success-for-sanofiregeneron-ra-drug-sarilumab/
41 SECNIDAZOLE
SYMBIOMIX
Solosec | FDA | 9/15/2017 | To treat bacterial vaginosis Drug Trials Snapshot |
42 SAFINAMIDE
NEWRON PHARMA
- Chemistry Review(s) (PDF) for correct structure
Xadago | FDA 3/21/2017 | To treat Parkinson’s disease Press Release Drug Trials Snapshot |
43 Semaglutide
NOVO NORDISK
Ozempic | semaglutide | FDA
12/5/2017 |
To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot |
LINK https://newdrugapprovals.org/2013/07/22/a-survey-of-promising-late-stage-diabetes-drugs/
44 SOFOSBUVIR
45 TELOTRISTAT ETHYL
LEXICON
Xermelo | FDA
2/28/2017 |
To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot |
46 VABORBACTAM
THE MEDICINES CO
Vabomere | meropenem and vaborbactam | FDA
8/29/2017 |
To treat adults with complicated urinary tract infections Press Release Drug Trials Snapshot |
47 VALBENAZINE
NEUROCRINE
- Chemistry Review(s) (PDF)
Ingrezza | FDA
4/11/2017 |
To treat adults with tardive dyskinesia Press Release Drug Trials Snapshot |
48 Vestronidase alfa-vjbk
ULTRAGENYX
Mepsevii | vestronidase alfa-vjbk | FDA 11/15/2017 | To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. Press Release Drug Trials Snapshot |
49 VELPATASVIR
50 VOXILAPREVIR
GILEAD
Vosevi | sofosbuvir, velpatasvir and voxilaprevir | FDA 7/18/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
SECTION B; EMA approvals
European Medicines Agency’s – Human medicines: Highlights of 2017
Advances in medicines authorizations are essential for public health as they have the potential to improve treatment of diseases. In 2017, EMA recommended 92 medicines for marketing authorization. Of these, 35 had a new active substance, which has never been authorized in the European Union (EU) before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies42. Amongst the 35 new active substances (NAS) that EMA recommended, 11 were new drugs and biologics to treat cancer, 05 to treat neurological disorders, 04 for infectious diseases, 04 for immunology/rheumatology, 03 for endocrinology, 02 each for Uro-nephrology, haematology, and dermatology, 01 for Pneumonology, and 01 for hepatology/gastroenterology class of drugs.
EUROPE
2017/11/16 | Niraparib | Zejula | Tesaro UK Limited | O | NME | ||
2017/11/10 | Adalimumab | Cyltezo | Boehringer Ingelheim International GmbH | B | |||
2017/11/10 | Miglustat | Miglustat Gen.Orph | Gen.Orph | G | |||
2017/11/10 | Ritonavir | Ritonavir Mylan | MYLAN S.A.S | G | |||
2017/11/10 | Padeliporfin | Tookad | STEBA Biotech S.A | ||||
2017/11/10 | Guselkumab | Tremfya | Janssen-Cilag International N.V. | BLA | |||
2017/9/27 | Dupilumab | Dupixent | sanofi-aventis groupe | BLA | |||
2017/9/21 | Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide | Symtuza | Janssen-Cilag International N.V. | ||||
2017/9/21 | Atezolizumab | Tecentriq | Roche Registration Limited | BLA | |||
2017/9/18 | Avelumab | Bavencio | Merck Serono Europe Limited | O | BLA | ||
2017/9/18 | Entecavir | Entecavir Mylan | Mylan S.A.S | G | |||
2017/9/18 | Lacosamide | Lacosamide Accord | Accord Healthcare Ltd | G | |||
2017/9/18 | Midostaurin | Rydapt | Novartis Europharm Ltd | O | NME | ||
2017/9/18 | Telotristat ethyl | Xermelo | Ipsen Pharma | O | NME | ||
2017/9/5 | Trientine | Cuprior | GMP-Orphan SA | ||||
2017/9/5 | Efavirenz / Emtricitabine / Tenofovir disoproxil | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S | G | |||
2017/8/24 | Tivozanib hydrochloride monohydrate | Fotivda | EUSA Pharma (UK) Limited | NME | |||
2017/8/24 | Adalimumab | Imraldi | Samsung Bioepis UK Limited (SBUK) | B | |||
2017/8/24 | Nitisinone | Nitisinone MDK (previously Nitisinone MendeliKABS) | MendeliKABS Europe Ltd | G | |||
2017/8/22 | Ribociclib | Kisqali | Novartis Europharm Ltd | NME | |||
2017/8/22 | Cladribine | Mavenclad | Merck Serono Europe Limited | ||||
2017/7/26 | Glecaprevir / Pibrentasvir | Maviret | AbbVie Limited | NME | |||
2017/7/26 | Sofosbuvir / Velpatasvir / Voxilaprevi | Vosevi | Gilead Sciences International Ltd | NME | |||
2017/7/19 | Insulin lispro | Insulin lispro Sanofi | sanofi-aventis groupe | B | |||
2017/7/19 | Patiromer sorbitex calcium | Veltassa | Vifor Fresenius Medical Care Renal Pharma France | NME | |||
2017/7/17 | Efavirenz / Emtricitabine / Tenofovir disoproxil | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva k.s. | G | |||
2017/7/17 | Brodalumab | Kyntheum | LEO Pharma A/S | BLA | |||
2017/7/17 | beclometasone / formoterol / glycopyrronium bromide | Trimbow | Chiesi Farmaceutici S.p.A. | ||||
2017/7/13 | Rituximab | Blitzima | Celltrion Healthcare Hungary Kft. | B | |||
2017/7/13 | Cariprazine | Reagila | Gedeon Richter | ||||
2017/7/10 | Spheroids of human autologous matrix-associated chondrocytes | Spherox | CO.DON AG | ||||
2017/7/6 | Cenegermin | Oxervate | Dompe farmaceutici s.p.a. | O | BLA | ||
2017/6/29 | Inotuzumab ozogamicin | Besponsa | Pfizer Limited | O | BLA | ||
2017/6/23 | Etanercept | Erelzi | Sandoz GmbH | ||||
2017/6/23 | Sarilumab | Kevzara | Sanofi-Aventis Groupe | NME | |||
2017/6/23 | Dimethyl fumarate | Skilarence | Almirall S.A | ||||
2017/6/23 | Carglumic acid | Ucedane | Lucane Pharma | G | |||
2017/6/15 | Rituximab | Rixathon, Riximyo B | Sandoz GmbH | ||||
2017/6/2 | Pentosan polysulfate sodium | Elmiron | bene-Arzneimittel GmbH | ||||
2017/6/2 | Nonacog beta pegol | Refixia | Novo Nordisk A/S | BLA | |||
2017/5/30 | Cerliponase alfa | Brineura | BioMarin International Limited | O E | BLA | ||
2017/5/30 | Nusinersen | Spinraza | Biogen Idec Ltd | O | NME | ||
2017/5/24 | Meningococcal group b vaccine (recombinant, adsorbed) | Trumenba | Pfizer Limited | ||||
2017/5/22 | Ivabradine | Ivabradine Accord | Accord Healthcare Ltd | G | |||
2017/5/8 | Dinutuximab beta | Dinutuximab beta Apeiron | Apeiron Biologics AG | O E | |||
2017/4/28 | Emtricitabine – tenofovir disoproxil mixt | Emtricitabine/Tenofovir disoproxil Krka d.d. | KRKA, d.d., Novo mesto | G | |||
2017/4/24 | Parathyroid hormone | Natpar | Shire Pharmaceuticals Ireland Ltd | O C | BLA | ||
2017/4/20 | Edoxaban | Roteas | Daiichi Sankyo Europe GmbH | ||||
2017/3/22 | Tofacitinib citrate | Xeljanz | Pfizer Limited | NME | |||
2017/3/20 | Umeclidinium | Rolufta | GlaxoSmithKline Trading Services Limited | ||||
2017/3/3 | Chlormethine | Ledaga | Actelion Registration Ltd. | O | |||
2017/2/27 | Pregabalin | Pregabalin Zentiva | Zentiva k.s. | G | |||
2017/2/17 | Rituximab | Truxima | Celltrion Healthcare Hungary Kft. | B | |||
2017/2/13 | Etanercept | Lifmior | Pfizer Limited | ||||
2017/2/13 | Baricitinib | Olumiant | Eli Lilly Nederland B.V. | NME | |||
2017/1/19 | Mercaptamine | Cystadrops | Orphan Europe S.A.R.L. | O | |||
2017/1/18 | Bezlotoxumab | Zinplava | Merck Sharp & Dohme Limited | NME | |||
2017/1/11 | Teriparatide | Movymia | STADA Arzneimittel AG | B | |||
2017/1/11 | Insulin glargine / lixisenatide | Suliqua | Sanofi-Aventis Groupe | ||||
2017/1/9 | Insulin aspart | Fiasp | Novo Nordisk A/S | ||||
2017/1/9 | Tadalafil | Tadalafil | Mylan S.A.S | G | |||
2017/1/9 | Tenofovir alafenamide | Vemlidy | Gilead Sciences International Ltd | ||||
2017/1/4 | Lonoctocog alfa | Afstyla | CSL Behring GmbH | BLA | |||
2017/1/4 | Darunavir | Darunavir Mylan | Mylan S.A.S. | G | |||
2017/1/4 | Insulin glargine | Lusduna | Merck Sharp & Dohme Limited | B | |||
2017/1/4 | Teriparatide | Terrosa | Gedeon Richter Plc. | B |
SECTION B; EMA Approvals
Combined drugs USFDA+EMA +PMDA list are listed below. trying to simplify search
1 Abaloparatide USFDA
2 Abemaciclib USFDA
3 ACALABRUTINIB USFDA
3A ALOFISEL EMA
3B AMENAMEVIR JAPAN
4 ANGIOTENSIN II USFDA
4A Atezolizumab EMA
5 AVELUMAB USFDA+EMA
6 BENRALIZUMAB USFDA+EMA
6A BARICITINIB JAPAN
7 BENZNIDAZOLE USFDA
8 BETRIXABAN USFDA
9 BRIGATINIB USFDA
10 BRODALUMAB USFDA+EMA
10A BUROSUMAB EMA
10B CARIPRAZINE HYDROCHLORIDE EMA
11 CERLIPONASE ALPA USFDA+EMA
12 COPANLISIB USFDA
13 DEFLAZACORT USFDA
14 Delafloxacin USFDA
15 Deutetrabenazine USFDA
16DUPILUMAB USFDA+EMA
17 DURVALUMAB USFDA
18 EDAVARONE USFDA
19 EMICIZUMAB USFDA
20 Enasidenib USFDA
21 ERTUGLIFLOZIN USFDA
22 ETELCALCETIDE USFDA
22A FORODESINE JAPAN
22B FLUCICLOVINE EMA
23 GLECAPREVIR USFDA+EMA
24 GUSELKUMAB USFDA+EMA
25 INOTUZUMAB OZOGAMICIN USFDA+EMA
26 LATANOPROSTENE USFDA
27 LETERMOVIR USFDA+EMA
27A Utetium lu 177 dotatate EMA
28 MACIMORELIN ACETATE USFDA
29 MEROPENEM USFDA
30 MIDOSTAURIN USFDA+EMA
31 NALDEMEDINE USFDA
32 NERATINIB USFDA
33 NETARSUDIL USFDA
34A NONACOG EMA
34B NUCINERSEN EMA +Japan
35 Ocrelizumab USFDA+EMA
35A OXERVATE EMA
36 OZENOXACIN USFDA
36A PATIROMER EMA
36B PADELIPORFIN EMA
36C PEMAFIBRATE JAPAN
37 PIBRENTASVIR USFDA+EMA
38 PLECANATIDE USFDA
39A ROLAPITANT EMA
39BRURLOCTOCOG EMA
40 SARILUMAB USFDA+EMA
41 SECNIDAZOLE USFDA
42 SAFINAMIDE USFDA
43 SEMAGLUTIDE USFDA+EMA
43A SODIUM ZIRCONIUM CYCLOCYLICATE EMA
44 SOFOSBUVIR USFDA+EMA
44A SPHEROX EMA
45 TELOTRISTAT ETHYL USFDA+EMA
45A TIVOZANIB EMA
45B TOFACITINIB EMA
45C TRUMENBA EMA
46 VABORBACTAM USFDA
47 VALBENAZINE USFDA
48 VESTRONIDASE ALFA-VJBK USFDA
49 VELPATASVIR USFDA+EMA
50 VOXILAPREVIR USFDA+EMA
Drugs EMA list missed out in usfda list
3A ALOFISEL
link………https://newdrugapprovals.org/2018/03/02/alofisel-darvadstrocel-cx-601/
4A Atezolizumab
WILL BE UPDATED
10A BUROSUMAB
WILL BE UPDATED
10B CARIPRAZINE HYDROCHLORIDE
WILL BE UPDATED
22B FLUCICLOVINE
SEE EMA
Axumin : EPAR – Summary for the public | EN = English | 06/07/2017 |
27A Lutetium lu 177 dotatate
WILL BE UPDATED
34A NONACOG
WILL BE UPDATED
34B NUCINERSEN
EMA AND JAPAN 2017 APPROVED
35A OXERVATE
WILL BE UPDATED
36A PATIROMER
WILL BE UPDATED
36B PADELIPORFIN
NAME | Tookad |
---|---|
AGENCY PRODUCT NUMBER | EMEA/H/C/004182 |
ACTIVE SUBSTANCE | padeliporfin di-potassium |
INTERNATIONAL NON-PROPRIETARY NAME(INN) OR COMMON NAME | padeliporfin |
THERAPEUTIC AREA | Prostatic Neoplasms |
ANATOMICAL THERAPEUTIC CHEMICAL (ATC) CODE | L01XD07 |
ADDITIONAL MONITORING | This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring. |
MARKETING-AUTHORISATION HOLDER | STEBA Biotech S.A |
---|---|
REVISION | 0 |
DATE OF ISSUE OF MARKETING AUTHORISATION VALID THROUGHOUT THE EUROPEAN UNION | 10/11/2017 |
Contact address:
STEBA Biotech S.A
7 place du theatre
L-2613 Luxembourg
Luxembourg
38A PRALATREXATE
Japan approved 2017
2017/7/3 | PMDA | JAPAN | Pralatrexate | Difolta | Mundipharma | NME |
39A ROLAPITANT
WILL BE UPDATED
39B RURLOCTOCOG
WILL BE UPDATED
43A SODIUM ZIRCONIUM
WILL BE UPDATED
44A SPHEROX
WILL BE UPDATED
45A TIVOZANIB
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Treatment of advanced renal cell carcinoma
Fotivda : EPAR -Product Information
Tivozanib is synthesized in three main steps using well defined starting materials with acceptable
specifications.
Adequate in-process controls are applied during the synthesis. The specifications and control methods for
intermediate products, starting materials and reagents have been presented. The critical process
parameters are duly justified, methodology is presented and control is adequate.
The characterisation of the active substance and its impurities are in accordance with the EU guideline on
chemistry of new active substances. Potential and actual impurities were well discussed with regards to
their origin and characterised.
The active substance is packaged in a low-density polyethylene (LDPE) bag which complies with the EC
directive 2002/72/EC and EC 10/2011 as amended.
Product details
Name | Fotivda |
---|---|
Agency product number | EMEA/H/C/004131 |
Active substance | tivozanib |
International non-proprietary name(INN) or common name | tivozanib hydrochloride monohydrate |
Therapeutic area | Carcinoma, Renal Cell |
Anatomical therapeutic chemical (ATC) code | L01XE |
Publication details
Marketing-authorisation holder | EUSA Pharma (UK) Limited |
---|---|
Revision | 0 |
Date of issue of marketing authorisation valid throughout the European Union | 24/08/2017 |
Contact address:
EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead, HP2 4TZ
United Kingdom
45B TOFACITINIB
WILL BE UPDATED
45C TRUMENBA
WILL BE UPDATED
SECTION C JAPANFORODOS
SECTION C New Drugs JAPAN
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html
JAPAN 2017
2017/9/27 | Avelumab (genetical recombination) | Bavencio | Merck Serono | BLA |
2017/9/27 | Glecaprevir – pibrentasvir mixt | Maviret | Abbvie | NME |
2017/9/27 | Daratumumab (genetical recombination) | Darzalex | Janssen Pharmaceutical | BLA |
2017/9/27 | Belimumab (genetical recombination) | Benlysta | GlaxoSmithKline | BLA |
2017/9/27 | Bezlotoxumab (genetical recombination) | Zinplava | MDS | BLA |
2017/9/27 | Palbociclib | Ibrance | Pfizer | NME |
2017/9/27 | Lonoctocog alfa (genetical recombination) | Afstyla | CSL Behring | BLA |
2017/9/27 | Rupatadine fumarate | Rupafin | Teikoku seiyaku | NME |
2017/9/27 | Sarilumab (genetical receombination) | Kevzara | Sanofi | BLA |
2017/9/27 | Flutemetamol (18F) | Vizamyl | Nihon Medi-Physics | NME |
2017/7/3 | Nusinersen sodium | Spinraza | Biogen Japan | |
2017/7/3 | Romidepsin | Istodax | Celgene | NME |
2017/7/3 | Pralatrexate | Difolta | Mundipharma | NME |
2017/7/3 | Amenamevir | Amenalief | Maruho | NME |
2017/7/3 | Baricitinib | Olumiant | Lilly | NME |
2017/7/3 | Pemafibrate | Parmodia | Kowa | NME |
2017/3/30 | Human prothrombin complex, freeze-dried concentrated | Kcentra | CSL Behring | |
2017/3/30 | Ixazomib citrate | Ninlaro | Takeda | NME |
2017/3/30 | Forodesine hydrochloride | Mundesine | Mundipharma | |
2017/3/30 | Aflibercept beta (genetical recombination) | Zaltrap | Sanofi | |
2017/3/30 | Hydromorphone hydrochloride | Narusus, Narurapid | DaiichiSankyo-pp | |
2017/3/30 | Naldemedine tosylate | Symproic | Shionogi | NME |
2017/3/30 | Guanfacine hydrochloride | Intuniv | Shionogi |
3B AMENAMEVIR
Originally developed by Astellas, the drug was licensed to Maruho. Amenamevir treats herpes zoster by inhibiting the activity of the helicase-primer enzyme during viral DNA replication and blocking the virus’s proliferation.
Amenalief® is an oral film-coated tablet containing 200 mg of amenamevir per tablet. Recommended dose of 1 day, 400mg each time, after meals.
22A FORODESINE HYDROCHLORIDE
LINK https://newdrugapprovals.org/2018/03/06/forodesine-hydrochloride/
6A BARICITINIB JAPAN
Originally developed by Incyte, Baricitinib was later licensed to and for sale by Lilly under the trade name Olumiant®. Baricitinib is an irreversible inhibitor of Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2). Olumiant® is approved for the treatment of mild to moderate rheumatoid arthritis in adult patients who are not responsive or intolerant to other anti-arthritic drugs. This product can be used alone or in combination with methotrexate.
Olumiant® is a film-coated tablet containing 2 mg or 4 mg per tablet. Recommended oral dose is 4mg daily, with meals or fasting food, you can take any time period.
2017/7/3PMDA Baricitinib Olumiant Lilly
36C PEMAFIBRATE
LINK https://newdrugapprovals.org/2016/04/24/pemafibrate/
SECTION D
CDSCO INDIA
http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11 http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11
KEEP WATCHING UNDER CONSTRUCTION AND WILL BE PASTED SOON………………………………………..
KEEP WATCHING UNDER CONSTRUCTION AND WILL BE PASTED SOON………………………………………..
KEEP WATCHING UNDER CONSTRUCTION AND WILL BE PASTED SOON………………………………………..
KEEP WATCHING UNDER CONSTRUCTION AND WILL BE PASTED SOON………………………………………..
REFERENCES
2 http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/01/WC500242079.pdf
“NEW DRUG APPROVALS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent
amcrasto@gmail.com
I , Dr A.M.Crasto is writing this blog to share the knowledge/views, after reading Scientific Journals/Articles/News Articles/Wikipedia. My views/comments are based on the results /conclusions by the authors(researchers). I do mention either the link or reference of the article(s) in my blog and hope those interested can read for details. I am briefly summarising the remarks or conclusions of the authors (researchers). If one believe that their intellectual property right /copyright is infringed by any content on this blog, please contact or leave message at below email address amcrasto@gmail.com. It will be removed ASAP
////////EMA APPROVALS, USFDA Approvals, ACALABRUTINIB, AVELUMAB, BETRIXABAN, BRODALUMAB, COPANLISIB, DEFLAZACORT, Delafloxacin, Deutetrabenazine, DUPILUMAB, ETELCALCETIDE, Naldemedine, NETARSUDIL, NIRAPARIB, Ocrelizumab, PLECANATIDE, RIBOCICLIB, SAFINAMIDE, TELOTRISTAT ETHYL, VALBENAZINE, CERLIPONASE, BRIGATINIB, MIDOSTAURIN, Abaloparatide, BENZNIDAZOLE, NERATINIB, inotuzumab ozogamicin, Enasidenib, LETERMOVIR, GLECAPREVIR, PIBRENTASVIR, VOXILAPREVIR, SOFOSBUVIR, EDAVARONE, abemaciclib, ANGIOTENSIN II, VESTRONIDASE, macimorelin acetate, ERTUGLIFLOZIN, SEMAGLUTIDE, EMICIZUMAB, eu 2017, fda 2017, BENRALIZUMAB, DURVALUMAB, GUSELKUMAB, LATANOPROSTENE, OZENOXACIN, SARILUMAB, SECNIDAZOLE, BENRALIZUMAB, TIVOZANIB, SARILUMAB, FLUCICLOVINE,
Ribociclib, рибоциклиб , ريبوسيكليب , 瑞波西利
Ribociclib
Ribociclib (LEE 011)
CAS: 1211441-98-3
Chemical Formula: C23H30N8O
Exact Mass: 434.25426
7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide
FDA UNII
-
TK8ERE8P56
Current developer: Novartis /Astex Pharmaceuticals.
Novartis Ag, Astex Therapeutics Ltd.
NMR.http://file.selleckchem.com/downloads/nmr/S744002-LEE011-2-HNMR-Selleck%20.pdf
http://file.selleckchem.com/downloads/hplc/S744002-LEE011-2-HPLC-Selleck.pdf
Ribociclib (LEE011) is an orally available, and highly specific CDK4/6 inhibitor. Phase 3.
CDK4 AND 6
(Cell-free assay)Product Ingredients
NOW FDA APPROVED 2017 since the blog post was written
Kisqali | FDA 3/13/2017 | To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot |
INGREDIENT | UNII | CAS | INCHI KEY |
---|---|---|---|
Ribociclib hydrochloride | 63YF7YKW7E | 1211443-80-9 | JZRSIQPIKASMEV-UHFFFAOYSA-N |
Ribociclib succinate | BG7HLX2919 | 1374639-75-4 | NHANOMFABJQAAH-UHFFFAOYSA-N |
RIBOCICLIB SUCCINATE
STRUCTURE ….LINK
Ribociclib is in phase III clinical trials by Novatis for the treatment of postmenopausal women with advanced breast cancer.
Phase II clinical trials are also in development for the treatment of liposarcoma, ovarian cancer, fallopian tube cancer, peritoneum cancer, endometrial cancer, and gastrointestinal cancer.
Ribociclib, also known as LEE011, is an orally available cyclin-dependent kinase (CDK) inhibitor targeting cyclin D1/CDK4 and cyclin D3/CDK6 cell cycle pathway, with potential antineoplastic activity. CDK4/6 inhibitor LEE011 specifically inhibits CDK4 and 6, thereby inhibiting retinoblastoma (Rb) protein phosphorylation. Inhibition of Rb phosphorylation prevents CDK-mediated G1-S phase transition, thereby arresting the cell cycle in the G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth. Overexpression of CDK4/6, as seen in certain types of cancer, causes cell cycle deregulation
Orally bioavailable CDK4/6-selective inhibitor that has been tested in Phase III clinical trials for treatment of advanced breast cancer.
CDK full name of cyclin-dependent kinases, there are many other subtypes CDK1-11, capable of binding to cell cycle proteins regulate the cell cycle. Pfizer Palbociclib been submitted for FDA review under phase II clinical data, Novartis Ribociclib (LEE011), Lilly Abemaciclib (LY2835219) the three CDK4 / 6 inhibitors have entered late stage development for the treatment of breast cancer
SYNTHESIS
WO2010020675
US20120115878
WO2010020675
http://www.google.co.in/patents/WO2010020675A1?cl=en
Example 74
7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide
Following Buchwald Method B, then General Procedure A, 2-chloro-7-cyclopentyl-7H- pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide (300 mg, 1.02 mmol) and 5-piperazin-1- yl-pyridin-2-ylamine (314 mg, 1.13 mmol) gave 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2- ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide (142 mg, 36%). MS(ESI) m/z 435.3 (M+H)+
POSTER
SYNTHESIS
TAKEN FROM ….http://www.joygooo.com/news_71.htm?pageNum=21
PCT Int Appl, WO2012061156.
US Pat Appl Publ, US20120115878
PCT Int Appl, WO2011130232 5) Brain, Christopher Thomas et al; Preparation of pyrrolopyrimidine Derivatives for Use as CDK4 / 6 inhibitors;. PCT Int Appl, WO2011101409.
PCT Int Appl, WO2011101417. 7) Besong, Gilbert et al;.
PCT Int Appl, WO2010020675.
PCT Int Appl, WO2007140222.
Reference:1. WO2012064805A1 / US20120115878A1.
2. WO2010020675A1 / US8415355B2.
3. WO2011130232A1 / US20130035336A1.
Clinical Trial Information( data from http://clinicaltrials.gov, updated on 2015-10-17)
NCT Number | Recruitment | Conditions | Sponsor /Collaborators |
Start Date | Phases |
---|---|---|---|---|---|
NCT02571829 | Not yet recruiting | Liposarcoma|Soft Tissue Sarcoma | Hadassah Medical Organization | December 2015 | Phase 2 |
NCT02524119 | Not yet recruiting | Hepatocellular Carcinoma | University of Texas Southwestern Medical Center|Novartis …more | November 2015 | Phase 2 |
NCT02494921 | Recruiting | Prostate Cancer | Rahul Aggarwal|University of California, San Francisco | September 2015 | Phase 1|Phase 2 |
NCT02420691 | Recruiting | Gastrointestinal Cancer | M.D. Anderson Cancer Center|Novartis | August 2015 | Phase 2 |
NCT02431481 | Not yet recruiting | Normal Renal Function|Impaired Renal Function | Novartis Pharmaceuticals|Novartis | August 2015 | Phase 1 |
Protocols from literature
In vitro protocol:: |
Pharmacologic growth inhibition: Clin Cancer Res. 2013 Nov 15;19(22):6173-82. Cell-cycle analysis: Clin Cancer Res. 2013 Nov 15;19(22):6173-82. Senescence and apoptosis assays: Clin Cancer Res. 2013 Nov 15;19(22):6173-82. |
In vivo protocol: |
Xenograft therapeutic trials: Clin Cancer Res. 2013 Nov 15;19(22):6173-82 Immunohistochemistry of xenografted neuroblastomas.Clin Cancer Res. 2013 Nov 15;19(22):6173-82 |
Ribociclib (LEE011) is a Me-Too version of palbociclib. Their structures are compared side-by-side as the following:
Ribociclib (LEE011) is currently being developed by Novartis and Astex. According its Novartis’s website, LEE011 is a novel, orally available, selective inhibitor of CDK4/6 kinases, which induces complete dephosphorylation of Rb and G1 arrest in cancer cells. In preclinical in vitro and in vivo tumor models, LEE011 has been shown active in cancers harboring aberrations that increase CDK4/6 activity, including those directly linked to the kinases as well as activating alterations in the upstream regulators. First-in-human study of LEE011 in patients with solid tumors and lymphoma is currently ongoing. (source: http://www.novartisoncology.us/research/pipeline/lee011.jsp).
Treatment with LEE011 significantly reduced proliferation in 12 of 17 human neuroblastoma-derived cell lines by inducing cytostasis at nanomolar concentrations (mean IC50 = 307 ± 68 nmol/L in sensitive lines). LEE011 caused cell-cycle arrest and cellular senescence that was attributed to dose-dependent decreases in phosphorylated RB and FOXM1, respectively. In addition, responsiveness of neuroblastoma xenografts to LEE011 translated to the in vivo setting in that there was a direct correlation of in vitro IC50 values with degree of subcutaneous xenograft growth delay. Although our data indicate that neuroblastomas sensitive to LEE011 were more likely to contain genomic amplification of MYCN (P = 0.01), the identification of additional clinically accessible biomarkers is of high importance. LEE011 is active in a large subset of neuroblastoma cell line and xenograft models, and supports the clinical development of this CDK4/6 inhibitor as a therapy for patients with this disease. (Clin Cancer Res. 2013 Nov 15;19(22):6173-82)
References |
1. Rader J, Russell MR, Hart LS, Nakazawa MS, Belcastro LT, Martinez D, Li Y, Carpenter EL, Attiyeh EF, Diskin SJ, Kim S, Parasuraman S, Caponigro G, Schnepp RW, Wood AC, Pawel B, Cole KA, Maris JM. Dual CDK4/CDK6 inhibition induces cell-cycle arrest and senescence in neuroblastoma. Clin Cancer Res. 2013 Nov 15;19(22):6173-82. doi: 10.1158/1078-0432.CCR-13-1675. Epub 2013 Sep 17. PubMed PMID: 24045179; PubMed Central PMCID: PMC3844928.
2. Caponigro, Giordano; Stuart, Darrin; Kim, Sunkyu; Loo, Alice; Delach, Scott. Pharmaceutical combinations of a CDK4/6 inhibitor and a B-RAF inhibitor for treatment of proliferative diseases such as cancer. PCT Int. Appl. (2014), WO 2014018725 A1 20140130.
3. Kim, Sunkyu; Doshi, Shivang; Haas, Kristy; Kovats, Steven; Huang, Alan Xizhong; Chen, Yan. Combination therapy comprising a cyclin dependent kinase 4/6 (CDK4/6) inhibitor and a phosphatidylinositol 3-kinase (PI3K) inhibitor for use in the treatment of cancer. PCT Int. Appl. (2013), WO 2013006532 A1 20130110
4. Kim, Sunkyu; Doshi, Shivang; Haas, Kristy; Kovats, Steven. Combination of cyclin dependent kinase 4/6 (CDK4/6) inhibitor and fibroblast growth factor receptor (FGFR) kinase inhibitor for the treatment of cancer. PCT Int. Appl. (2013), WO 2013006368 A1 20130110
5. Calienni, John Vincent; Chen, Guang-Pei; Gong, Baoqing; Kapa, Prasad Koteswara; Saxena, Vishal. Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof. U.S. Pat. Appl. Publ. (2012), US 20120115878 A1 20120510.
6. Borland, Maria; Brain, Christopher Thomas; Doshi, Shivang; Kim, Sunkyu; Ma, Jianguo; Murtie, Josh; Zhang, Hong. Combination comprising a cyclin dependent kinase 4 or cyclin dependent kinase (cdk4/6) inhibitor and an Mtor inhibitor for treating cancer. PCT Int. Appl. (2011), WO 2011130232 A1 20111020
7. Besong, Gilbert; Brain, Christopher Thomas; Brooks, Clinton A.; Congreve, Miles Stuart; Dagostin, Claudio; He, Guo; Hou, Ying; Howard, Steven; Li, Yue; Lu, Yipin; et al. Preparation of pyrrolopyrimidine compounds as CDK inhibitors. PCT Int. Appl. (2010), WO 2010020675 A1 20100225.
CLIP
Cyclin-dependent kinase inhibitors (14 compounds) under clinical evaluation.
LEE-011 is one of the most selective inhibitors for CDK4 and CDK6 [59] and is being developed by Astex Pharmaceuticals™ and Novartis. In January 2014 this inhibitor entered phase III clinical trials for the treatment of breast cancer [60]. Due to encouraging results LEE-011 has now become the main competing drug-candidate with Pfizer’s PD0332991 (palbociclib), see Figure 3 [59].
Upon comparison of the chemical structure of Novartis’ LEE-011 and Pfizer’s PD0332991, the similarity is evident. The major difference lies in the bicyclic core since LEE-011 possesses a pyrrolo-pyrimidine and PD0332991 a pyridopyrimidine. The “east” part of the structure is also modified. The structural similarities make their analogous CDKs inhibition profiles (high selectivity for CDK4 and CDK6) quite obvious Moreover, both derivatives are orally administered which is pretty advantageous compared with dinaciclib, which is also in phase III clinical trials but is administered intravenously.
http://www.mdpi.com/1420-3049/19/9/14366/htm
- Kurt, S. LEE011 CDK Inhibitor Showing Early Promise in Drug-Resistant Cancers. Oncol. Times 2014, 36, 39–40. [Google Scholar]
- Macmillan Publishers Limited. CDK inhibitors speed ahead. Nat. Rev. Drug Discov. 2014, 13, 323. [Google Scholar] [CrossRef]
Sources:
1)Rader, JulieAnn et al.;Dual CDK4/CDK6 Inhibition Induces Cell-Cycle Arrest and Senescence in Neuroblastoma;Clinical Cancer Research (2013), 19(22), 6173-6182
2)Tavares, Francis X. and Strum, Jay C.;Preparation of pyrazinopyrrolopyrimidine derivatives and analogs for use as CDK inhibitors;PCT Int. Appl., WO2012061156
3)Calienni, John Vincent et al.;Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof;U.S. Pat. Appl. Publ., US20120115878
4)Borland, Maria et al;Combination comprising a cyclin dependent kinase 4 or cyclin dependent kinase (cdk4/6) inhibitor and an Mtor inhibitor for treating cancer;PCT Int. Appl., WO2011130232
5)Brain, Christopher Thomas et al;Preparation of pyrrolopyrimidine derivatives for use as CDK4/6 inhibitors;PCT Int. Appl., WO2011101409
6)Brain, Christopher Thomas and Perez, Lawrence Blas; Preparation of deuterated pyrrolopyrimidine compounds as inhibitors of CDK4/6 for treating cancer; PCT Int. Appl., WO2011101417
7)Besong, Gilbert et al.;Preparation of pyrrolopyrimidine compounds as CDK inhibitors;PCT Int. Appl., WO2010020675
8)Brain, Christopher Thomas et al.;Preparation of pyrrolopyrimidine compounds as protein kinase inhibitors; PCT Int. Appl., WO2007140222
9)A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease;ClinicalTrials.gov Identifier: NCT01958021
/////////Ribociclib, novartis, LEE011, astex, phase 3, CDK inhibitors
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