Biogen Idec and Orphan Biovitrum present data on hemophilia study

The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

"Current prophylactic regimens for hemophilia B require intravenous injections twice per week, so there is great desire among physicians and patients for a therapy that will provide prolonged protection from bleeding," said Amy Shapiro, M.D., Medical Director of the Indiana Hemophilia and Thrombosis Center. "Results from the Phase 1/2a trial show that rFIXFc may be able to reduce the number of injections to once weekly or less, which would be an important advancement for the hemophilia community."

Based on positive results from the Phase 1/2a trial, rFIXFc was advanced into a global registrational trial called B-LONG in January. B-LONG is designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in 75 previously-treated people with severe hemophilia B. rFIXFc's ability to prevent bleeding using different dosing regimens is being measured by evaluating the number of breakthrough bleeding episodes.

Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. The companies recently announced their decision to advance rFVIIIFc into a registrational trial based on positive results from a Phase 1/2a open-label, cross-over, dose-escalation study designed to evaluate the safety and pharmacokinetics of rFVIIIFc in people with severe hemophilia A.

Source: Biogen Idec