The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B.
Using the company's novel and proprietary monomeric Fc fusion technology, clotting factor rFIXFc provides long-lasting protection from bleeding and reduces the treatment burden associated with hemophilia B.
The application included results from B-LONG phase 3 clinical study, which the company claims is the largest registrational in hemophilia B to date.
The study demonstrated that rFIXFc provides long-lasting protection from bleeding with fewer injections than are required with the current standard of care.
In response to the application, the FDA has granted the company a standard review timeline.
Biogen Idec hemophilia therapeutic area chief medical officer and global medical affairs senior vice president Glenn Pierce said, "We are working with the FDA to bring the first major treatment advance for the hemophilia B community in 15 years."
The company also announced that its BLA submission for rFVIIIFc for use in patients with hemophilia A is on track for filing during the first half of 2013.
