Alprolix rFIXFc regulatory update

FDA approved a BLA from Biogen Idec 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 said Alprolix is the world's first approved long-acting hemophilia B therapy. The FDA approval came about a week after Health Canada approved Alprolix (see BioCentury, March 24).

Alprolix is under review in Australia and Japan. The product has Orphan Drug status in the U.S. and Orphan Drug designation in the EU for hemophilia B. ...