BioCentury
ARTICLE | Company News

EMA accepts alirocumab MAA

January 13, 2015 3:24 AM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) said Monday that EMA accepted for review their MAA for Praluent alirocumab to treat hypercholesterolemia. The companies also revealed that they submitted a BLA to FDA for the human mAb targeting proprotein convertase subtilisin/kexin type 9 ( PCSK9) in 4Q14. Regeneron and Sanofi are co-developing the compound under a 2007 deal.

Amgen submitted a BLA to FDA and an MAA to EMA for competing PCSK9 inhibitor evolocumab last year. FDA accepted the BLA in November (see BioCentury Extra, Sept. 2, 2014). ...