US FDA clears Biogen Idec and SOBI's Alprolix for hemophilia B

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration late Friday approved biotech firm Biogen Idec’s (Nasdaq: BIIB) Alprolix, coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have hemophilia B.

Alprolix, under development with Swedish Orphan Biovitrum (STO: SOBI), is the first hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. It is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis).

“The approval of this product provides another therapeutic option for the treatment and prevention of bleeding in patients with hemophilia B,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.