correction: corrects the headline to say the FDA has accepted the BLA, not approved.
Biogen Idec Inc. (BIIB), a developer and marketer of therapies for the treatment of neurodegenerative diseases, hemophilia, and autoimmune disorders, Monday announced that the US Food and Drug Administration or the FDA accepted the Biologics License Application or BLA for the marketing approval of ELOCTATE(recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A.
The ELOCTATE BLA was based on results from A-LONG, a phase 3 clinical study in hemophilia A to date. In the A-LONG study, patients who injected ELOCTATE once-weekly to twice-weekly had low annualized bleeding rates. With the FDA's acceptance of the ELOCTATE BLA, the firm now has product candidates for both hemophilia A and B under review with the agency.
Hemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. ELOCTATE is a clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway to delay the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.
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