Canada approves Biogen Idec's Alprolix rFIXFc

Health Canada approved Alprolix rFIXFc from Biogen Idec Inc. (NASDAQ:BIIB) to prevent and control bleeding episodes and for routine prophylaxis in hemophilia B patients 12 years of age and older. Biogen Idec and partner Swedish Orphan Biovitrum AB (SSE:SOBI) said the product is the world's first approved long-acting hemophilia B therapy. This is also the first worldwide approval for Alprolix, which is under review in the U.S., Australia and Japan. Biogen Idec said it plans to make Alprolix available in Canada in "the very near future," but said reimbursement negotiations in the country may take up to a year. The product is a recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1. ...