Biogen Idec and Sobi announce positive top-line results from phase 3 study in hemophilia B

28-Sep-2012 - Sweden

Biogen Idec and Swedish Orphan Biovitrum (Sobi)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.

https://www.bionity.com/en/news/139945/biogen-idec-and-sobi-announce-positive-top-line-results-from-phase-3-study-in-hemophilia-b.html