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July 24 2013 | By Márcio Barra
Roche has announced that its experimental leukemia drug GA101, or obinutuzumab, used in combination with chemotherapy, was better than Rituxan at helping people with chronic lymphocytic leukemia live longer without their disease worsening, according to the results from the second phase of the clinical trial. Both drugs were tested and compared in combination with chlorambucil.
The trial, named CLL11, is a phase III, multicenter, open-label, randomized three-arm study investigated in 781 previously untreated people with chronic lymphocytic leukemia and co-existing medical conditions who are in need of therapy. The study included two stages of analysis, with the first stage results being reported at the start of this month. Data from the first stage showed that patients taking Obinutuzumab had a 86%reduction in the risk of disease worsening or death when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with chronic…
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July 24 2013 | By Márcio Barra
Evaluate Pharma has released today their sixth edition of their series EvaluatePharma’s World Preview. Like always, it is filled with high-quality data on the (mostly) post-patent cliff world that we live in, worthy of a careful read. Some highlights of the report follow:
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Alkermes has unveiled three new drug candidates, including: a monomethyl fumarate (MMF) prodrug programme for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic.
According to Alkermes, these drug candidates demonstrate the company’s focus on unmet medical needs in specific patient populations and show the productivity of its expanded R&D capabilities.
read all at
http://www.manufacturingchemist.com/news/article_
page/Alkermes_unveils_three_new_drug_candidates/90167
Written by Michael Sapko for drugs.com
.http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1
There are a number of medical treatments available to manage ulcerative colitis. Modern therapy is targeted at preventing flares and inducing remission (at least temporarily). These medications, however, have serious side effects, especially when taken for long periods. Corticosteroids, for example, can cause a number of cosmetic, psychological, and hormonal problems. Many patients simply cannot tolerate these medications. Children have particular problems with standard medications. When compliance with prescribed medicines is poor, treatment failure is common.1,2 Thus, many patients turn to natural remedies for their ulcerative colitis..http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1
Some herbal or organic remedies may help promote gut health and prolong the time between remissions (flares).
A few well-known home remedies for the management of ulcerative colitis include:
continue…………………………………………….
read all at
http://www.drugs.com/health/ulcerative-colitis/natural-remedy-1234/#1
CHICAGO—The U.S. Food and Drug Administration (FDA) has recently approved PROCYSBI(cysteamine bitartrate), a delayed release capsule for treating nephropathic cystinosis in adults and children 6 years and older.
Ann and Robert H. Lurie Children’s Hospital of Chicago served as one of three United States sites for the landmark study and patients came from all over North America to be seen by lead investigator, Craig B Langman, M.D., The Isaac A Abt, M.D. professor of Kidney Diseases at Northwestern University Feinberg School of Medicine and head of Kidney Diseases at Lurie Children’s
Kyowa Hakko Kirin Co., Ltd. has been filed an application to Japan’s Ministry of Health, Labour and Welfare (“MHLW”) seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO® Injection 20 mg).
read at…………
Mogamulizumab (USAN; trade name Poteligeo) is a humanized monoclonal antibodytargeting CC chemokine receptor 4 (CCR4). It has been approved in Japan for the treatment of relapsed or refractory adult T-cell leukemia/lymphoma.[1]
Mogamulizumab was developed by Kyowa Hakko Kirin Co., Ltd.[2] It has also been licensed to Amgen for development as a therapy for Asthma.[3]
| 单克隆抗体Poteligeo（mogamulizumab）获得日本厚生劳动省批准治疗白血病-淋巴瘤 日本厚生劳动省批准Kyowa Hakko Kirin公司的Poteligeo治疗复发或难治性CC趋化因子受体4（CCR4，CD194）阳性的T细胞性白血病-淋巴瘤。厚生劳动省还批准了Kyowa公司这一抗体的两个诊断方法，用于测试IHC和FCM，从而确定最有可能对治疗有应答的患者亚群。Amgen公司拥有Poteligeo在除日本、韩国、中国大陆和台湾以外地区的所有非癌症适应症的开发和商业化独占权。Amgen公司正在进行本品用于治疗哮喘的Ⅰ期临床研究。 |
Tacrolimus
July 19, 2013 /PRNewswire/ — Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.
“Each transplant recipient is different and requires a personalized treatment approach. The approval of Astagraf XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney t recipients,” said Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc. “Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology.”
Tacrolimus (also FK-506 or fujimycin, trade names Prograf, Advagraf, Protopic) is an immunosuppressive drug that is mainly used after allogeneic organ transplant to reduce the activity of the patient’s immune system and so lower the risk of organ rejection. It is also used in a topical preparation in the treatment of atopic dermatitis (eczema), severe refractory uveitis after bone marrow transplants, exacerbations of minimal change disease, and the skin condition vitiligo.
It is a 23-membered macrolide lactone discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. It reduces interleukin-2 (IL-2) production by T-cells.
Tacrolimus was discovered in 1984; it was among the first macrolide immunosuppressants discovered, preceded by the discovery of rapamycin (sirolimus) on Rapa Nui (Easter Island) in 1975.It is produced by a type of soil bacterium, Streptomyces tsukubaensis. The name tacrolimus is derived from ‘Tsukuba macrolide immunosuppressant’.
Tacrolimus 0.1%
Tacrolimus was first approved by the Food and Drug Administration (FDA) in 1994 for use in liver transplantation; this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.
The branded version of the drug is owned by Astellas Pharma, and is sold under the trade names Prograf given twice daily, Advagraf, a sustained release formulation allowing once daily dosing, and Protopic (Eczemus in Pakistan by Brookes Pharma), the topical formulation. Advagraf is available in 0.5, 1, 3 and 5 mg capsules, the ointment is concentrations of 0.1% and 0.03%.
A second once-daily formulation of tacrolimus is in Phase 3 clinical trials in the U.S. and Europe. This formulation also has a smoother pharmacokinetic profile that reduces the peak-to-trough range in blood levels compared to twice-daily tacrolimus.Data from the first Phase 3 trial in stable kidney transplant patients showed that this once-daily formulation was non-inferior in efficacy and safety compared to twice-daily tacrolimus. A second Phase 3 trial in de novo patients is ongoing.
July 22 2013 | By Márcio Barra
Latest update – July 29, 2013
Prevenar 13, or Prevnar 13 as it is known in the U.S., is a 13-valent pneumococcal conjugate vaccine marketed by Pfizer inc. and manufactured by its Wyeth division, used to immunize and protect against Streptococcus pneumoniae infection. This vaccine is the direct successor of the vaccine Prevenar, and is currently the best-selling vaccine in the world (1). The first Prevenar was a 7-valent vaccine that contained 7 different outer sugar coating (polysaccharides) from 7 different Streptococcus pneumoniae serotypes: 4, 6B, 9V, 14, 18C, 19F, and 23F. Each serotype was conjugated to diphtheria toxoid CRM197 protein, which acts as an immunologic carrier (2) (3).
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The recent availability of databases that provide both phenotypic descriptions and the chemical structures of the constituent compounds in traditional Chinese and Indian medicines, have enabled Bender et al (J. Chem. Inf. Model. 2013 (53) 661 – 673, DOI: 10.1021/ci3005513 , http://www.andreasbender.de/) to develop a cool algorithm to predict the mode of action (MOA) of these compounds and to predict novel protein targets for cancer therapies.
Traditional medicine has been utilised by human for thousands of years and normally viewed as complementary or alternative to mainstream therapies. However, both Chinese and traditional Indian medicine (Ayervedic) have provided us with important drugs for instance Artemisinin an antimalarial drug and reserpine an antihypertensive drug.
From 1981 to 2007, 67% of the pharmaceuticals or new molecular entities (NMEs) introduced into the market were natural product based or a derivative there of. These natural products often have desirable properties which make them…
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THIS IS DEC2012 COMPILATION. READER MAY ENCOUNTER AN APPROVED OR DROPPED ENTRY
A variety of new drugs are in development for the treatment of type 1 or type 2 diabetes. In addition to new dipeptidyl peptidase-4 (DPP-IV) inhibitors, glucagon-like peptide (GLP) 1 analogs, basal insulin analogs, and new insulin formulations, there are also unique dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist, G-protein-coupled receptor (GPR) 40 agonist, sodium dependent glucose transporter 2 (SGLT2) inhibitor, and several other unique agents now in development.
A list of 25 drug candidates has been compiled for which diabetes is at least one proposed or approved indication, and for which one indication has reached Phase III or Registration phases. Each entry includes the name of the drug candidate, the sponsor, and, where applicable, chemical structures, collaboration partners; method of action; indication (by market, where applicable); and phase of trial. Some products are still in clinical trial phases for new indications or formulations after winning marketing approval for initial indications; these approvals, where applicable, are listed on the bottom of each entry.
Sponsor/Developer: GlaxoSmithKline; developed by Human Genome Sciences, which licensed the drug for late-stage trials before Glaxo acquired HGS in a $3 billion deal completed Aug. 3
Mechanism of action: Glucagon-like peptide (GLP) 1 agonist
Indication (Phase): Once-weekly for type 2 diabetes (Phase III completed; NDA expected to be filed early 2013)
Sponsor/Developer: Takeda Pharmaceuticals and Furiex Pharmaceuticals
Mechanism of action: DPP-4 inhibitor
Indication (Phase): U.S.—Oral treatment of type 2 diabetes, individually and as a fixed-dose combination (FDC) with the thiazolidinedione pioglitazone (Registration; NDA re-submitted July 2012 after initial NDA rejected via complete response letter April 2012)
EU—Oral treatment of type 2 diabetes (Registration; MAA submission accepted May 2012)
Japan—Marketed as Nesina®; Approved 2011 for oral treatment of type 2 diabetes as FDC with pioglitazone; Approved 2010 for oral treatment of type 2 diabetes
Update: On January 25, 2013, U.S. Food and Drug Administration approved Takeda Pharmaceutical Co’s alogliptin to treat type 2 diabetes as a standalone drug and in two other formulations in combination pills with older diabetes medicines. Alogliptin by itself will be sold under the brand name Nesina. The drug in combination with metformin will be sold as Kazano, and alogliptin along with pioglitazone – the chemical name for Takeda’s Actos – will be sold as Oseni.
Chemical Structure of Alogliptin (Nesina®)
Chemical Name: 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile
CAS number: 850649-62-6
Sponsor/Developer: Astellas; co-developed with Kotobuki
Mechanism of action: Sodium dependent glucose transporter 2 (SGLT2) inhibitor
Indication (Phase): Japan—Type 2 diabetes with inadequate glycemic control while on a sulfonylurea or pioglitazone alone (Phase III)
U.S. and EU—Development discontinued “after comprehensive consideration of intensified competition for this product, and the prioritization in our pipeline”
Sponsor/Developer: Johnson & Johnson (Janssen Research & Development); licensed from Mitsubishi Tanabe Pharma
Mechanism of action: SGLT2 inhibitor
Indication (Phase): U.S.—Once-daily oral treatment for adults with type 2 diabetes (registration; NDA filed May 2012)
EU—Once-daily oral treatment for adults with type 2 diabetes (registration; MAA filed June 2012)
Canagliflozin is the most advanced diabetes therapy in the pipeline at J&J.
Chemical Structure of Canagliflozin
Chemical Name for Canagliflozin: (2S,3R,4R,5S,6R)-2-{3-[5-[4-Fluoro-phenyl)-thiophen-2-ylmethyl]-4-methyl-phenyl}-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
CAS number: 842133-18-0
Sponsor/Developer: GlaxoSmithKline; developed by Human Genome Sciences, which licensed the drug for late-stage trials before Glaxo acquired HGS in a $3 billion deal completed Aug. 3.
Mechanism of action: Lp-PLA2 inhibitor
Indication (Phase): U.S.—Diabetic macular edema (DME; Phase II as of July 2012; expected to be completed December 2012); Atherosclerosis (Phase III; AIM III study recruiting patients as of November 2012); Atherosclerosis (Phase III; ongoing but not recruiting patients); Chronic coronary heart disease (Phase III; STABILITY trial, ongoing but not recruiting patients as of November); Cardiovascular event (heart attack or stroke) within 30 days after an acute coronary syndrome (Phase III; ongoing but not recruiting as of November 2012); Severe renal impairment (Phase I; recruiting as of November 2012)
EU—DME (Phase II)
Chemical Structure of Darapladib (SB-480848)
Chemical Name for Darapladib (SB-480848): N-(2-diethylaminoethyl)-2-[2-[(4-fluorophenyl)methylsulfanyl]-4-oxo-6,7-dihydro-5H-cyclopenta[d]pyrimidin-1-yl]-N-[[4-[4-(trifluoromethyl)phenyl]phenyl]methyl]acetamide
CAS number: 356057-34-6
Sponsor/Developer: Eli Lilly
Mechanism of action: GLP-1 analog
Indication (Phase): Once-weekly, for type 2 diabetes (Phase III; results from three of five AWARD trials released Oct. 22; AWARD 2 and 4 results to be released “in the next few months”; major cardiovascular events and other serious outcomes in persons with type 2 diabetes (Phase III; REWIND trial, recruiting as of November 2012); Type 2 diabetes compared with glimepiride, liraglutide, insulin glargine (Phase III; recruiting as of November 2012); Japanese participants with type 2 diabetes, with monotherapy of oral antihyperglycemic medications (Phase III; recruiting as of November 2012); Chinese participants with type 2 diabetes (Phase III; recruiting as of November 2012)
NDA to be submitted in 2013
https://newdrugapprovals.wordpress.com/2013/06/25/dulaglutide-shows-superiority-in-phase-3-trials/
Sponsor/Developer: Eli Lilly and Boehringer Ingelheim
Mechanism of action: SGLT 2 inhibitor
Indication (Phase): Oral treatment of adults with type 2 diabetes (Phase III, expected to conclude by year’s end); Oral treatment of adults with type 2 diabetes plus high blood pressure (Phase IIb; trial results released Oct. 2)
NDA, MAA filings planned for 2013
Chemical Structure of Empagliflozin (BI10773)
Chemical name of Empagliflozin (BI10773): (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
CAS number：864070-44-0
Sponsor/Developer: Bristol-Myers Squibb and AstraZeneca
Mechanism of action: SGLT2 inhibitor
Indication (Phase): EU—Approved Nov. 14 as once-daily oral medication for adults with type 2 diabetes; first SGLT2 drug to gain such approval
U.S.—Once-daily oral medication for adults with type 2 diabetes (Registration; FDA in October 2012 postpones decision three months pending submission of additional clinical trial data; complete response letter issued January 2012; FDA Endocrinologic and Metabolic Drugs Advisory Committee recommends against approval, July 2011; NDA filed March 2011)
Japan—Diabetes (Registration; NDA expected to be filed in first half of 2013)
Forxiga is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes. Dapagliflozin is awaiting approval in the USA, where the Food and Drug Administration earlier this year issued a complete response letter requesting additional data.
In addition to dapagliflozin, AstraZeneca and Bristol-Myers Squibb’s diabetes alliance included the approved DPP-4 inhibitor Onglyza (saxagliptin) and a form of the drug combined with metformin called Kombiglyze.
Chemical Structure of Dapagliflozin (Forxiga)
Chemical Name of Dapagliflozin (Forxiga): (2S,3R,4R,5S,6R)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
CAS number: 461432-26-8
Sponsor/Developer: Novo Nordisk
Mechanism of action: Combination of Tresiba® (insulin degludec) and Victoza® (liraglutide)
Indication (Phase): Type 2 diabetes (Phase IIIa; DUAL II study, expected to be completed by year’s end); Type 2 diabetes in patients previously inadequately controlled on one or two oral anti-diabetic drugs (Phase IIIa; DUAL I study, results released August 2012)
Sponsor/Developer: San
Lantus® (insulin glargine)
ofi
Mechanism of action: Human insulin analog
Indication (Phase): U.S.—Prediabetes or early type 2 diabetes with high cardiovascular risk (Phase III; ORIGIN study; results announced Oct. 5); Approved for adults and children with type 1 diabetes, and adults with type 2 diabetes
EU—On May 25, European Commission approved changing the indication to “Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above,” from “treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required”
https://newdrugapprovals.wordpress.com/?s=Lantus%C2%AE+%28insulin+glargine%29&submit=
Sponsor/Developer: Sanofi; in-licensed from Zealand Pharma
Mechanism of action: GLP-1 agonist
Indication (Phase): U.S.—Once-daily, for adults with type 2 diabetes with oral glucose-lowering medicinal products and/or basal insulin (Phase III results announced June 2012; NDA expected by year’s end)
EU—Once-daily, for adults with type 2 diabetes with oral glucose-lowering medicinal products and/or basal insulin (Registration; MAA submitted November 2011; recommended for approval by Committee for Medicinal Products for Human Use (CHMP) on Nov. 15)
Sponsor/Developer: Eli Lilly and Boehringer Ingelheim
Mechanism of action: Basal insulin analog
Indication (Phase): Adults with type 1 diabetes, compared with insulin glargine and insulin lispro (Phase III; IMAGINE 1 study; ongoing but not recruiting as of November 2012); Adults with type 1 diabetes, compared with insulin glargine and insulin lispro (Phase III; IMAGINE 3 study; recruiting as of November 2012); Adults with type 2 diabetes, compared with insulin glargine and insulin lispro (Phase III; IMAGINE 4 study; recruiting as of November 2012); Adults with type 2 diabetes, compared with insulin glargine (Phase III; IMAGINE 2 and IMAGINE 5 studies; recruiting as of November 2012); Adults with type 1 diabetes, compared with insulin glargine (Phase I); Patient reported results from Phase II announced Oct. 2
Sponsor/Developer: Eli Lilly and Boehringer Ingelheim
Mechanism of action: Basal insulin analog
Indication (Phase): Type 1diabetes, compared with Lantus and Insulin Lispro (Phase III; ELEMENT I study ongoing but not recruiting as of August 2012); Type 2 diabetes, compared with Lantus and oral antihyperglycemic medications (Phase III; ELEMENT II study completed as of September 2012); Comparison to Lantus, healthy participants (Phase I, completed September 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, recruiting as of September 2012); Type 1 diabetes, comparison to Lantus (Phase I, completed July 2012); Comparison to Lantus, pharmacokinetics and pharmacodynamics (Phase I, completed July 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, completed 2011)
Sponsor/Developer: Bristol-Myers Squibb; Developed by Amilyn Pharmaceuticals, acquired by BMS in a $7 billion deal completed Aug. 8
Mechanism of action: Leptin analog
Indication (Phase): Diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy (Registration; BLA submitted April 2012; Fast Track designation)
Sponsor/Developer: Merck & Co.
Mechanism of action: DPP-4 inhibitor
Indication (Phase): Once-weekly for adults with type 2 diabetes: Comparison with Sitagliptin in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Comparison with chronic kidney disease or kidney failure on dialysis (Phase III; recruiting as of November 2012); Add-on to oral antihyperglycemic agent study in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Compared with glimepiride in participants with type 2 diabetes who have inadequate glycemic control on metformin (Phase III; recruiting as of November 2012); Adults with type 2 diabetes and inadequate glycemic control following combination therapy of glimepiride and metformin (Phase III; recruiting as of November 2012); Phase IIb results announced in October 2012
Merck is the dominant player in the market for diabetes drugs known as DPP-4 inhibitors, with the blockbuster success of its first-in-class therapy Januvia (Sitagliptin). And the Whitehouse Station, NJ-based pharma giant has built a pipeline of novel and combo therapies that could build on this position.In September, Merck published phase 2b results for MK-3102 that showed efficacy and safety nearly even with Januvia. Janumet is more effective for some patients, since it’s a combination of Januvia and metformin, but MK-3102 is convenient with a once-weekly dosage.
Chemical Structure of Januvia(Sitagliptin Phosphate):
Sponsor/Developer: Johnson & Johnson and Grunenthal
Mechanism of action: Centrally-acting synthetic analgesic; agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor
Indication (Phase): Approved August 2012 for diabetic peripheral neuropathy (extended release formulation)
Sponsor/Developer: Gilead
Mechanism of action: Late sodium current inhibitor
Indication (Phase): Type 2 diabetes (Phase III)
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone (currently recruiting participants as of August 2012, ClinicalTrials.gov Identifier: NCT01555164, see the link here)
Chemical Structure of Ranolazine
Chemical Name of Ranolazine: (RS)-N-(2,6-dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)-propyl]piperazin-1-yl]acetamide
CAS number: 142387-99-3
Ranolazine, developed by CV Therapeutics whom Gilead Sciences bought in 2009, is also sold under the trade name Ranexa for the treatment of chronic angina (chest pain).
Sponsor/Developer: Roche
Mechanism of action: Dual peroxisome proliferator-activated receptor (PPAR) α/γ activation
Indication (Phase): Cardiovascular risk reduction in type 2 diabetes (Phase III; NDA filing expected 2015)
Chemical Structure of RG1439 (aleglitazar)
Chemical Name of RG1439 (aleglitazar) : (2S)-2-methoxy-3-[4-[2-(5-methyl-2-phenyl-4-oxazolyl)ethoxy]- 7-benzothiophenyl]propanoic acid
CAS number : 475479-34-6
Sponsor/Developer: Novo Nordisk
Mechanism of action: Soluble fixed combination of basal insulin with bolus insulin aspart
Indication (Phase): U.S.—Once daily for type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)
EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP)
Sponsor/Developer: Novo Nordisk
Mechanism of action: GLP-1 analog
Indication (Phase): Once-weekly for type 2 diabetes (Phase III; SUSTAIN™ study, set to start first half of 2013)
Sponsor/Developer: Ajinomoto and Astellas
Mechanism of action: Insulin secretion enhancer
Indication (Phase): Japan—Type 2 diabetes, with DPP-4 inhibitors (Phase III; new indication)
Sponsor/Developer: Takeda
Mechanism of action: G-protein-coupled receptor (GPR) 40 agonist
Indication (Phase): Asia-Pacific adults with type 2 diabetes (Phase III; GRAND-307 study, recruiting as of November 2012); Diabetic patients, compared with Glimepiride (Phase III; recruiting as of November 2012); Adults with type 2 diabetes, with metformin, compared with Glimepiride (Phase III; GRAND-305 study, recruiting as of August 2012); Adults with type 2 diabetes (Phase III; recruiting as of August 2012); Adults with type 2 diabetes, compared to placebo and sitagliptin with metformin (Phase III; recruiting as of August 2012); Adults with type 2 diabetes and cardiovascular disease (Phase III; recruiting as of August 2012)
Sponsor/Developer: Roche and Chugai Pharmaceutical
Mechanism of action: SGLT2 inhibitor
Indication (Phase): Oral treatment for type 2 diabetes (Phase III)
Sponsor/Developer: Takeda Pharmaceuticals and Furiex Pharmaceuticals
Mechanism of action: DPP-4 inhibitor
Indication (Phase): Japan—Once-weekly oral treatment for type 2 diabetes (Phase III; study expected to be completed in second half of 2013)
Sponsor/Developer: Novo Nordisk
Mechanism of action: Once-daily basal insulin
Indication (Phase): U.S.—Type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)
EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP in 100 units/mL and 200 units/mL formulations, the latter would be the first insulin in Europe to be marketed at a higher strength than 100 units/mL)
Japan—Approved September 2012 for type 1 and type 2 diabetes
New Drug Approvals 