Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF,SNY) Monday said the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application or BLA for Praluent (alirocumab).
Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) intended for the treatment of patients with hypercholesterolemia.
Under the Prescription Drug User Fee Act, the goal for a priority review is six months, for a target action date of July 24.
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 over 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to around 5 years.
Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union.
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