Biogen Idec files for US approval of long-acting hemophilia A treatment

US biotech firm Biogen Idec (Nasdaq: BIIB) says it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for approval to market its recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A.

Recombinant FVIIIFc is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition. If approved, rFVIIIFc will be the first major advance in hemophilia A treatment in more than two decades, the company noted. The regulatory submission was based on results from A-LONG, the largest registrational Phase III clinical study in hemophilia A to date.

“This regulatory submission marks another significant step toward our goal of transforming the care of hemophilia for patients, families and caregivers,” said Glenn Pierce, senior vice president of global medical affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area.”