BioCentury
ARTICLE | Company News

FDA accepts Amgen's evolocumab BLA

November 11, 2014 3:12 AM UTC

FDA accepted for review a BLA from Amgen Inc. (NASDAQ:AMGN) for evolocumab ( AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9, to treat high cholesterol. The application is the first in the U.S. for a PCSK9 program and has a PDUFA date of Aug. 27, 2015.

By year end, Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) plan to submit a BLA to FDA for alirocumab, a competing human mAb targeting PCSK9. The companies intend to use a Priority Review voucher to expedite the review, which could allow the partners to leapfrog Amgen in the race to market (see BioCentury, Aug. 4). ...