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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Drug Design:Discovery, Development and Delivery
Drug Design:Discovery, Development and Delivery
by Dr. Basavaraj Nanjwade
http://www.slideshare.net/bknanjwade/drug-designdiscovery-development-and-delivery
http://www.slideshare.net/bknanjwade/drug-designdiscovery-development-and-delivery
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HERBAL AND DRUG DESIGN TECHNOLOGY
- 9,572 views
an introduction to drug discovery ON SLIDESHARE
http://www.slideshare.net/bishorvi/introduction-to-drug-discovery
http://www.slideshare.net/bishorvi/introduction-to-drug-discovery
http://www.slideshare.net/bishorvi/introduction-to-drug-discovery
Amgen sets up China JV with Zhejiang Beta for Panitumumab,Vectibix
Amgen is expanding its activities in China and establishing a joint venture with Zhejiang Beta Pharma Co to sell its colon cancer drug Vectibix, Panitumumab.
http://www.pharmatimes.com/Article/13-05-10/Amgen_sets_up_China_JV_with_Zhejiang_Beta.aspx
Panitumumab (INN), formerly ABX-EGF, is a fully human monoclonal antibody specific to the epidermal growth factor receptor (also known as EGF receptor, EGFR, ErbB-1 and HER1 in humans).
Panitumumab is manufactured by Amgen and marketed as Vectibix. It was originally developed by Abgenix Inc.
It was approved by the U.S. Food and Drug Administration (FDA) for the first time in September 2006, for “the treatment of EGFR-expressing metastatic colorectal cancer with disease progression” despite prior treatment. Panitumumab was approved by the European Medicines Agency (EMEA) in 2007, and by Health Canada in 2008 for “the treatment of refractory EGFR-expressing metastatic colorectal cancer in patients with non-mutated (wild-type) KRAS”.
Panitumumab was the first monoclonal antibody to demonstrate the use of KRAS as a predictive biomarker.
In July 2009, the FDA updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab and cetuximab) indicated for the treatment of metastatic colorectal cancer to include information about KRAS mutations.
FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
fluticasone furoate
vilanterol
May 10, 2013 — The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States.
Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.
The challenges facing the pharmaceutical industry through to 2020
The challenges facing the pharmaceutical industry through to 2020
link on slideshare is
by Irish Pharmaceutical Healthcare Association (IPHA) on Nov 12, 2009
- 22,073 views on slideshare
Presentation delivered by Mr Sandy Johnston, PriceWaterhouseCoopers at the Irish Pharmaceutical Healthcare Association Annual Meeting 2009.
US green light for Warner Chilcott’s new contraceptive
May 10, 2013
US regulators have issued a green light for Warner Chilcott’s new oestrogen/progestin-based oral contraceptive, which is yet to be given an official trade name.
The product is a chewable combination of norethindrone acetate and ethinyl estradiol and ferrous fumarate tablets, approved by the US Food and Drug Administration for the prevention of pregnancy.
The oral contraceptive regimen consists of 24 white active chewable tablets that contain the active ingredients, followed by four brown non-hormonal placebo tablets containing ferrous fumarate.
Approval was based on data from a six-month clinical trial involving 743 women aged 18-45 years, which showed the risk of getting pregnant to be about one-four in 100 women during the first year of use.
second nod, may10 2013–The US Food and Drug Administration has given the green light to Novartis’ Ilaris as a treatment for a serious form of childhood arthritis.
my old post for first nod
Novartis’ Ilaris canakizumab has become the first biologic drug to be approved in the EU to treat the symptoms of gouty arthritis
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL-1β |
Novartis’ Ilaris has become the first biologic drug to be approved in the EU to treat the symptoms of gouty arthritis in another gain for the interleukin-1 beta inhibitor.
march01,2013
First biologic drug approved for condition in Europe
The European Commission (EC) cleared llaris (canakizumab) for the treatment of adult patients who have suffered at least three gouty arthritis attacks in the previous 12 months, but who are unsuitable for treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine or repeated courses of corticosteroids.
Gouty arthritis – commonly known as gout – is an “excruciating condition”, according to Novartis division head David Epstein, who noted that Ilaris offers new hope to patients who do not currently have treatment options.
Data from two phase III trials of Ilaris in acute gouty arthritis attacks showed that patients treated with the drug experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide, while most adverse events were mild to moderate in severity.
The most frequent side effects were infections, and particularly upper respiratory tract infections and nasopharyngitis.
Ilaris was launched in the US and EU in 2009 as a treatment for an auto-inflammatory condition called cryopyrin-associated periodic syndrome (CAPS). The rarity of that condition has meant sales have been relatively small, coming in at $72m last year, albeit a 56 per cent gain over 2011.
Gouty arthritis is a much bigger market for the drug and, along with a juvenile arthritis indication Novartis is pursuing, could push Ilaris towards blockbuster status with sales in excess of $1bn a year.
“Our vision is to realise the potential of Ilaris wherever IL-1 beta plays a key role and available treatment options don’t give patients the help they need,” said Epstein.
EU approval comes after the US FDA knocked back Ilaris for gouty arthritis, saying in 2011 that Novartis needed to provide more data on the drug’s risk-benefit profile, specifically its potential to leave patients vulnerable to infections.
Gout has been a tricky indication for drug developers to crack, with the FDA turning down another CAPS treatment – Regeneron’s IL-1 inhibitor Arcalyst (rilonacept) – in 2012 on the grounds of inadequate safety data and concern about a risk of malignancy.
One success came in 2010 when Savient secured approval for its Krystexxa (pegloticase) drug as a second-line treatment after oral xanthine oxidase inhibitors in patients with severe debilitating chronic tophaceous gout.
However, the drug has failed to make significant inroads because of a high price and tendency to stimulate neutralising antibodies that limit its therapeutic effect, according to Decision Resources.
There is still a great demand for safer and more effective therapies with the phase III pipeline featuring another potential blockbuster in the form of AstraZeneca/Ardea Biosciences URAT1 inhibitor lesinurad.
Canakinumab (INN, trade name Ilaris, previously ACZ885)[1] is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha.[2]
Canakinumab was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the US FDA on June 2009[3] and by the European Medicines Agency in October 2009.[4] CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle–Wells syndrome, and neonatal-onset multisystem inflammatory disease.
Canakinumab was being developed by Novartis for the treatment of rheumatoid arthritis but this trial has been discontinued.[5] Canakinumab is also in phase I clinical trials as a possible treatment for chronic obstructive pulmonary disease.[6]
References
- Dhimolea, Eugen (2010). “Canakinumab”. MAbs 2 (1): 3–13. doi:10.4161/mabs.2.1.10328. PMC 2828573. PMID 20065636.
- Lachmann, HJ; Kone-Paut I, Kuemmerle-Deschner JB et al. (4 June 2009). “Use of canakinumab in the cryopyrin-associated periodic syndrome”. New Engl J Med 360 (23): 2416–25. doi:10.1056/NEJMoa0810787. PMID 19494217.
- “New biological therapy Ilaris approved in US to treat children and adults with CAPS, a serious life-long auto-inflammatory disease” (Press release). Novartis. 18 June 2009. Retrieved 28 July 2009.
- Wan, Yuet (29 October 2009). “Canakinumab (Ilaris) and rilonacept (Arcalyst) approved in EU for treatment of cryopyrin-associated periodic syndrome”. National electronic Library for Medicines. Retrieved 14 April 2010.
- “clinicaltrials.gov, Identifier NCT00784628: Safety, Tolerability and Efficacy of ACZ885 (Canakinumab) in Patients With Active Rheumatoid Arthritis”. Retrieved 2010-08-21.
- Yasothan U, Kar S (2008). “Therapies for COPD”. Nat Rev Drug Discov 7 (4): 285. doi:10.1038/nrd2533.
Monoclonal Antibody Therapeutic Uses
AtheroNova Receives Russia’s Approval for Phase I Clinical Trials
May 09, 2013
InSite Vision Initiates Confirmatory Phase 3 Clinical Study of BromSite™ for the Reduction of Inflammation and Pain after Cataract Surgery
bromfenac
may9, 2013
InSite Vision Incorporated today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain after cataract surgery. This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite drug delivery technology.
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) marketed in the US as anophthalmic solution (current brand name Bromday, prior formulation brand name Xibrom, which has since been discontinued.) by ISTA Pharmaceuticals for short-term, local use. Bromday® is the once-daily formulation of bromfenac, while Xibrom®, which has since been discontinued, was the twice-daily formulation. Bromfenac is indicated for the treatment of ocular inflammation and pain after cataract surgery, though it may be prescribed in an off-label manner by the physician.
For ophthalmic use, bromfenac has been prescribed more than 20,000,000 times across the world. As an eye drop, it has been available since 2000, starting in Japan where it was sold as Bronuck®. It was first FDA approved for use in the United States in 2005 and it was marketed as Xibrom®, twice-daily. October 2010 was the FDA approval of the new once-daily formulation of bromfenac called Bromday®. The bromfenac molecule will be marketed in Europe and other worldwide markets with agreements from Bausch & Lomb, Croma Pharma, and other companies.
Bromfenac was formerly marketed in the United States by Wyeth-Ayerst in an oral formulation called Duract® for short-term relief of pain (less than 10 days at a time). It was brought to market in July, 1997, and was withdrawn June 22, 1998 following numerous reports of hepatotoxicity in patients who had taken the medication for longer than the recommended 10-day period. The dose was one 25 mg capsule every 6 to 8 hours, or two capsules if taken with a high-fat meal, up to a maximum of 150 mg per day.
Array Announces Global Phase 3 Trial Evaluating MEK162 In Patients With Low-Grade Serous Ovarian Cancer
MEK-162:
5-((4-bromo-2-fluorophenyl)amino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzo[d]imidazole-6-carboxamide.
May 6, 2013
Array BioPharma Inc. today announced that it will initiate a global Phase 3 clinical trial in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. The study, called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), will evaluate the efficacy and safety of MEK162 compared to standard chemotherapy treatments and is designed for worldwide regulatory submissions, including with the U.S. Food and Drug Administration and the European Medicines Agency. Array invented MEK162 and licensed worldwide rights to develop and commercialize the drug to Novartis in April 2010. The MILO study follows a recent announcement by Novartis detailing plans to initiate Phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma and will be covered as part of the Novartis/Array co-development agreement under which costs are capped annually and in total for Array.
MEK162 (ARRY-162) is an oral, highly selective MEK inhibitor. In preclinical studies, MEK162 showed significant antitumor activities in cell lines and animal models. MEK162 is now being investigated in trials in advanced solid tumors. Recent research confirms that the MEK pathway acts as a central axis in the proliferation of different tumors including melanoma, non-small cell lung, head/neck and pancreatic cancers. And MEK inhibition, either alone or in combination with other agents, is an important therapeutic strategy in treating cancer. ARRY-162 is a novel, orally active, potent, selective, non-ATP-competitive inhibitor of MEK 1 / 2 that has the potential to treat a range of malignant diseases. (source:http://www.arraybiopharma.com/ProductPipeline/Cancer/MEK.asp).
1. Combinations comprising methotrexate and DHODH inhibitors By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From PCT Int. Appl. (2010), WO 2010083975 A1 20100729.
2. Combinations comprising methotrexate and DHODH inhibitors By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From Eur. Pat. Appl. (2010), EP 2210615 A1 20100728.
3. Combination of (a) a phosphoinositide 3-kinase inhibitor and (b) a modulator of Ras/Raf/Mek pathway By Garcia-Echeverria, Carlos; Maira, Sauveur-Michel; Stuart, Darrin; Wee, Susan; Fritsch, Christine; Nagel, Tobi From PCT Int. Appl. (2010), WO 2010006225 A1 20100114.
4. Combination comprising DHODH inhibitors and methotrexate for treatment of autoimmune, inflammatory and proliferative disorders By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From PCT Int. Appl. (2009), WO 2009153043 A1 20091223.
5. Combination comprising DHODH inhibitors and methotrexate for treatment of autoimmune, inflammatory and proliferative disorders By Godessart Marina, Nuria; Pizcueta Lalanza, Maria Pilar From Eur. Pat. Appl. (2009), EP 2135610 A1 20091223
New Drug Approvals 