BLA Submitted for Long-Lasting Factor IX Therapy for Hemophilia B

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Biogen Idec announced the company submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. rFIXFc is a clotting factor developed using proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life.

The regulatory submission was based on results from B-LONG, a registrational Phase 3 clinical study of patients with hemophilia B.

For more information visit www.biogenidec.com.

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