Biogen Idec, Sobi release data from rFVIIIFc and rFIXFc phase 3 trials on hemophilia

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia. The data, from the largest phase 3 registrational studies conducted in hemophilia to date, were presented this week at the 6th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD).

The studies compared the pharmacokinetic activity of rFVIIIFc for hemophilia A and rFIXFc for hemophilia B to currently available treatments. In the studies, the long-lasting candidates stayed active in the body longer, enabling study participants to prevent bleeding with less frequent injections than are required with the current standard of care. In the A-LONG study, patients with hemophilia A were able to use once to twice weekly prophylactic (preventative dosing) injections of rFVIIIFc while maintaining low bleeding rates. In the B-LONG study, rFIXFc allowed patients with hemophilia B to use prophylactic injections every one to two weeks with low bleeding rates.

"Data from these phase 3 trials demonstrate a potential to transform the treatment of hemophilia by offering long-lasting protection from bleeding while meaningfully reducing treatment burden associated with this rare disease," 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. "Less frequent injections may help more people with hemophilia adhere to a preventative treatment schedule, which can help prevent the long-term health consequences associated with treating a bleed after it occurs."

The current standard of care for hemophilia A and B requires frequent injections, which are a burden for patients. Prophylactic treatment for hemophilia A typically requires injections three times per week or every other day, and injections 2-3 times per week for the treatment of hemophilia B, according to the National Hemophilia Foundation's Medical and Scientific Advisory Council guidelines. People with severe hemophilia who do not follow a prophylactic injection schedule remain vulnerable to bleeding that can cause irreversible joint damage and life-threatening hemorrhages.

Recombinant FVIIIFc and recombinant FIXFc were developed using Fc fusion technology, which has safely been used in FDA-approved medicines for more than a decade. Biogen Idec and Swedish Orphan Biovitrum applied Fc fusion technology in hemophilia for the first time with the goal of making clotting factors last longer and reduce the burden of injections for patients and their families.


Biogen Idec



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