FDA accepts BLA from Biogen for Eloctate for treatment of Haemophilia A

Biogen Idec has announced that the FDA has accepted the company's Biologics License Application (BLA) for the marketing approval of Eloctate (recombinant factor VIII Fc fusion protein) for the treatment of Haemophilia A. Eloctate is the first Haemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and reducing the burden of treatment for patients with this chronic condition.

Eloctate has the potential to improve adherence by reducing the number of intravenous injections needed to prevent bleeds, which is an important need for people with Hemophilia A. The Eloctate BLA was based on results from A-LONG, the largest registrational phase III clinical study in hemophilia A to date.