FDA
10th June 2015

FDA Advisory Committee Supports Approval of Praluent® (alirocumab) Injection for Hypercholesterolemia

Yesterday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the approval of the investigational therapy Praluent® (alirocumab).

FDA Advisory Committee Supports Approval of Praluent® (alirocumab) Injection for Hypercholesterolemia

Yesterday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the approval of the investigational therapy Praluent® (alirocumab) Injection, a low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering drug. The materials for this meeting can be found HERE

The Committee voted 13 – 3, with no abstentions, that Regeneron and Sanofi had sufficiently established that the benefits of Praluent exceed its risks in one or more patient populations.

The Committee’s recommendation followed a review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging in duration from six months to two years. Both a 75 mg and 150 mg dose were investigated in trials. Clinical trial data from the ODYSSEY Phase 3 program demonstrated consistent, positive results in reducing LDL-C. Adverse events more frequently reported in patients treated with Praluent than control groups, included injection site reaction and pruritus (itching).

The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015.

If approved by the FDA, Praluent is expected to be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the U.S. The Marketing Authorization Application for Praluent in the European Union is currently under review by the European Medicines Agency (EMA). The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority.

George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President, Regeneron Laboratories stated, “The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade.”

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice, and will use it in their review of the Biologics License Application (BLA) for Praluent.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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