Alprolix rFIXFc regulatory update

Health Canada approved Alprolix rFIXFc from Biogen Idec to prevent and control bleeding episodes and for routine prophylaxis in hemophilia B patients >=12 years of age. The company 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. Biogen Idec and partner Swedish Orphan said the product is the 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. In December, Biogen Idec said FDA extended by 3 months the PDUFA date for a BLA for Alprolix. The new and original PDUFA dates are not disclosed; Biogen Idec submitted the BLA in 4Q12 (see BioCentury, Dec. 9, 2013). Alprolix has Orphan Drug designation in the U.S. and EU for hemophilia B. ...