FDA accepts cholesterol-lowering med BLA under priority review

• Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced that the FDA has accepted under priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
• Priority review status shortens the review time to six months so the PDUFA date is July 24.
• The European Medicines Agency accepted the companies' Marketing Authorization Application (MAA) several weeks ago.
• Alirocumab is an investigational monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9). It will be competing with Amgen's (NASDAQ:AMGN) evolocumab for supremacy in the post-statin anti-cholesterol market. The PDUFA date for the FDA's review of evolocumab is August 27.
• Previously: European regulator accepts Regeneron/Sanofi application for cholesterol-lowering med (Jan. 12)
• Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)