Biogen Idec announced that the FDA has accepted its Biologics License Application (BLA) for the marketing approval of Eloctate (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. With Biogen Idec’s monomeric Fc fusion technology, Eloctate makes use of a naturally occurring pathway to delay the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulation half-life.
Eloctate is the first hemophilia A product candidate in a new class of clotting factor therapies being developed to provide long-lasting protection and reduce the treatment burden in patients with this chronic condition.
On March 4, 2013, the FDA accepted for review Biogen Idec’s BLA for Alprolix (recombinant factor IX Fc fusion protein) for the treatment of hemophilia B.
For more information visit www.biogenidec.com.