FDA approves Biogen Idec's Alprolix for hemophilia B

FDA approved a BLA from Biogen Idec Inc. (NASDAQ:BIIB) for Alprolix rFIXFc to control and prevent bleeding episodes, manage bleeding during surgical procedures and as prophylaxis in hemophilia B patients. Biogen Idec said it plans to launch Alprolix in the U.S. in early May. The company has not yet set a price for the product, a recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1. Biogen Idec and partner Swedish Orphan Biovitrum AB (SSE:SOBI) said Alprolix is the world's first approved long-acting hemophilia B therapy. Health Canada approved Alprolix last week (see BioCentury Extra, March 21). ...