Sanofi’s mAb Gets FDA Priority ReviewBy
Sanofi and Regeneron Pharmaceuticals, Inc. report that U. Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for Praluent (alirocumab). Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia
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. 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.