Regeneron and Sanofi Announce Praluent Marketing Authorization Application has Been Accepted for Review by EMA

Regeneron and Sanofi have announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) 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.

The MAA for Praluent contains data from more than 5000 patients, including 10 Phase III ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial programme will include more than 23,500 patients at more than 2000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years.

A biologics license application (BLA) for Praluent was submitted to the FDA in the fourth quarter of 2014.

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.