Amgen submits evolocumab BLA

Amgen Inc. (NASDAQ:AMGN) submitted a BLA to FDA for evolocumab ( AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the U.S. for a PCSK9 program -- includes data from 10 Phase III trials. Separately, Amgen said evolocumab plus a statin met the co-primary endpoints vs. placebo in the Japanese Phase III YUKAWA-2 trial, which enrolled 404 patients with high cardiovascular risk and high cholesterol. Amgen said it plans to submit a regulatory application in the EU this quarter, with a submission in Japan slated for next year.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) are not far behind Amgen in the PCSK9 race, with plans to submit a BLA to FDA for alirocumab by year end. The partners plan to use a Priority Review voucher for the human mAb targeting PCSK9, which could help them close the gap with Amgen (see BioCentury, Aug. 4). ...