Replies to post #556834 on $Stock*Shop*Charts*News*Option$

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FDA accepts cholesterol-lowering med BLA under priority review

Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE: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.