Sanofi and Regeneron’s Praluent BLA gains priority review from US FDA

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab), which is under development by French pharma major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN).

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.

The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase III 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 around five years.