Sanofi+ Regeneron file MAA for Praluent at EMA to treat Hypercholesterolemia.

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Praluent (alirocumab). Praluent 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 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 approximately 5 years. A biologics license application (BLA) for Praluent was submitted to the FDA in the fourth quarter of 2014.

Comments: Alirocumab and evolocumab from Amgen (filed at FDA and EMA) are drugs of a new class of PCSK 9 inhibitors that seek to treat the large number of patients that fail to achieve cholesterol lowering on statins. Analysts expect both drugs to become blockbusters. Other PCSK 9 inhibitors in development include ALN.PCS (The Medicines Company/Alnylam), RN 316 (Pfizer) and RG 7652 ( Roche). Eli Lilly has a CEPT inhibitor,evacetlapib, in Phase II.