27 Jan 2015

Regeneron and Sanofi’s Praluent BLA Accepted for Priority Review by FDA

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Tagsalirocumab, ODYSSEY clinical trial program, Praluent, Regeneron Pharmaceuticals, Sanofi

Regeneron Pharmaceuticals and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.

Clinical Program outcome highlight

The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years.

Earlier this month, the companies announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.

Alirocumab is a human monoclonal antibody PCSK9 inhibitor designed for the treatment of hypercholesterolemia. It is also known as REGN727 and SAR236553. It was discovered by Regeneron Pharmaceuticals and is being co-developed with Sanofi.