Positive results from Sobi, Biogen Idec's rFIXFc Phase 3 trial on hemophilia B

Published on September 27, 2012 at 12:34 AM · No Comments

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced positive results from B-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia B. Hemophilia B is a rare inherited disorder that impairs blood coagulation.    

Top-line results from B-LONG, a global, multi-center, Phase 3 clinical study of the companies' long-lasting recombinant Factor IX Fc fusion protein (rFIXFc), showed that rFIXFc was effective in the control and prevention of bleeding, routine prophylaxis, and perioperative management. Recombinant FIXFc was generally well-tolerated. Additional analyses of the B-LONG study are ongoing and the companies anticipate presenting further results at a future scientific meeting.

Biogen Idec plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013. Consistent with guidelines published by the European Medicines Agency (EMA) that require a study in children less than 12 years of age prior to filing, Biogen Idec and Sobi expect to file a Marketing Authorization Application with the EMA upon completion of the ongoing Kids B-LONG study.

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