FDA news briefs: Biogen Idec's rFIXFc BLA accepted; 2nd CRL for Xarelto sNDA; negative vote on Depomed's Sefelsa and Hisamitsu's paroxetine mesylate

US biotech firm Biogen Idec (Nasdaq: BIIB) says that the Food and Drug Administration has accepted the company’s Biologics License Application for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline.

Recombinant FIXFc is the first product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for hemophilia B, according to Biogen Idec.

The regulatory submission was based on results from B-LONG, the largest registrational Phase III clinical study in hemophilia B to date. The study showed that rFIXFc provides long-lasting protection from bleeding with fewer injections than are required with the current standard of care. The company’s BLA submission for rFVIIIFc for use in patients with hemophilia A is on track for filing during the first half of 2013.