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First marketing approvals granted for two anti-PCSK9 antibody therapeutics

September 1, 2015 by The Antibody Society

Two human antibodies targeting proprotein convertase subtilisin/kexin type 9 have been granted first marketing approvals. On July 17, 2015, evolocumab (Repatha®), a human IgG2 antibody, was approved in the EU to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins, and to treat homozygous familial hypercholesterolemia. Alirocumab (Praluent®), a human IgG1 antibody, was approved by the US Food and Drug Administration (FDA) on July 24, 2015 for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. FDA also approved evolocumab on August 27, 2015.

Filed Under: Ab news, Approvals

Total of eight novel antibody therapeutics in EU or US regulatory review

August 28, 2015 by The Antibody Society

The number of antibody therapeutics recently granted first approvals in the EU and US will increase substantially if the 8 antibodies currently in regulatory review in these regions are granted marketing approvals. Three of these antibodies target cancerous cells. Necitumumab, a human IgG1 antibody targeting epidermal growth factor receptor, is undergoing review as a treatment for squamous non-small cell lung cancer.  In July 2015, a majority of the FDA’s Oncologic Drugs Advisory Committee agreed that necitumumab shows some promise in the first-line treatment of the disease. The anti-CD38 antibody daratumumab is under FDA review for multiple myeloma; the drug has Breakthrough Therapy and Fast Track designations for this indication. Elotuzumab, which targets the signaling lymphocyte activation molecule SLAMF7, is undergoing regulatory review in the EU for multiple myeloma. The European Medicines Agency (EMA) has granted an accelerated assessment of the marketing application.

An additional five antibodies are potential treatments for non-cancerous conditions. Two antibody therapeutics that target interleukin (IL)-5, mepolizumab and reslizumab, are undergoing review in the EU and US for asthma. Ixekizumab, which targets IL-17A, is being evaluated by EMA as a treatment for psoriasis. The protective antigen of B. anthracis exotoxin is the target of obiltoxaximab, which is undergoing review in the US for anthrax infection. Obiltoxaximab has Fast Track designation for this indication. The anti-dabigatron antibody idarucizumab is in US and EU review for reversal of dabigatron-induced anticoagulation; the drug has Breakthrough Therapy designation and its application will receive a priority review in the US.

Filed Under: Ab news, Approvals

Median review times in Japan decrease substantially in past decade

August 25, 2015 by The Antibody Society

In the recent report “New Drug Approvals in ICH Countries 2005-2014”, the Centre for Innovation in Regulatory Science has shown that, in 2014, Japan’s the Pharmaceuticals and Medical Devices Agency was the fastest regulatory agency, with a median approval time of 306 days for new active substances (NASs) compared to medians of 343 and 418 days for the FDA and EMA, respectively. Over the past decade, approval times at FDA and EMA have remained relatively stable, but Japan’s approval times have decreased substantially, e.g., from ~800 days in 2005 and 2006 to 306 days in 2014. A marketing application for brodalumab, which targets IL17 receptor, was recently submitted for review in Japan. Brodalumab is undergoing evaluation as a treatment for plaque psoriasis, psoriatic arthritis, pustular psoriasis, psoriatic erythroderma.

Filed Under: Ab news, Approvals

Collaboration to develop brodalumab halted

June 25, 2015 by The Antibody Society

Amgen announced that it commenced termination of a collaboration with AstraZeneca to develop brodalumab, a human IgG2 mAb targeting IL-17 receptor. Amgen recently presented data from three Phase 3 clinical trials evaluating brodalumab in patients with moderate-to-severe plaque psoriasis, and in connection with the presentation, suicidal ideation and completed suicides in the brodalumab program were noted. According to the company, the evidence to date does not suggest a causal association between IL-17 inhibition and suicidal ideation and behavior, but the events likely would necessitate restrictive labeling.

Filed Under: Ab news, Categorie 1

American Society of Clinical Oncology Annual meeting

June 24, 2015 by The Antibody Society

The American Society of Clinical Oncology’s Annual meeting was held May 29-June 2, 2015 in Chicago. The meeting features an extensive program of presentations on cancer therapies. Data for numerous antibodies, including avelumab, bavituximab, ensituximab, HuMax-Axl-ADC, OBT357/MEN1112, MEDI4736, MEDI0680, PF-05082566, NI-1701, SEA-CD40, REGN1979, and the CEA-directed BiTE MEDI-565/AMG 211 were made available in abstracts. The meeting abstracts can be accessed here.

Filed Under: Ab news, Categorie 1

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