BioCentury
ARTICLE | Company News

Hemo B therapies among several CHMP nods

February 27, 2016 12:57 AM UTC

EMA's CHMP recommended marketing authorization for several new medicines, including two to treat and prevent bleeding in hemophilia B patients: Alprolix eftrenonacog alfa from Biogen Inc. (NASDAQ:BIIB) and Idelvion albutrepenonacog alfa ( CSL654) albutrepenonacog alfa from CSL Ltd. (ASX:CSL).

Alprolix is a recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1. The drug, which FDA approved in 2014, is partnered with Swedish Orphan Biovitrum AB (SSE:SOBI). Idelvion, a recombinant fusion protein linking Factor IX with recombinant albumin, is also under review in the U.S., Switzerland and Japan. ...