EMA accepts Sanofi and Regeneron's MMA for Praluent for review
French drug major Sanofi (Euronext: SAN) and US biotech company Regeneron (Nasdaq: REGN) have announced that the European Medicines Agency has accepted their Marketing Authorization Application for Praluent (alirocumab) for review.
The drug is an investigational monoclonal targeting proprotein convertase subtilisin/kexin type 9 intended to treat hypercholesterolemia.
The MAA for Praluent contains data from more than 5,000 patients, and includes 10 Phase III ODYSSEY trials. 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. Its safety and efficacy have not been fully evaluated by any regulatory body.
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