Voucher puts alirocumab ahead in PCSK9 race

FDA accepted and granted Priority Review to a BLA for Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) to treat hypercholesterolemia.

Praluent's PDUFA date is July 24, more than one month ahead of that of evolocumab ( AMG 145) from Amgen Inc. (NASDAQ:AMGN). Both are human mAbs against proprotein convertase subtilisin/kexin type 9 ( PCSK9). Evolocumab's PDUFA date is Aug. 27 (see BioCentury Extra, Nov. 10, 2014). ...