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