Positive results from Sobi, Biogen Idec's rFIXFc Phase 3 trial on hemophilia B
Published on September 27, 2012 at 12:34 AM
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
"The results of the B-LONG study offer the potential for longer-lasting
protection from bleeding for patients with hemophilia B," said Glenn
Pierce, M.D., Ph.D., Senior Vice President of Global Medical Affairs and
Chief Medical Officer of Biogen Idec's hemophilia therapeutic area.
"Currently, prophylactic treatment of hemophilia B requires intravenous
injections up to three times a week, which makes the prospect of a
longer-lasting Factor IX therapy very exciting."
"Our companies are pioneering the application of Fc fusion technology to
extend the half-life of clotting factors. Fc fusion technology utilizes
a naturally-occurring recycling pathway that has been successfully
employed in other therapeutic areas. This approach holds promise for
combining more consistent protection with fewer injections," said
Geoffrey McDonough, M.D., Chief Executive Officer of Sobi. "The B-LONG
study results are highly encouraging and support the potential use of
this technology in hemophilia B."