Biogen Idec and Swedish Orphan Biovitrum (Sobi) have reported new Phase 3 data supporting the long-lasting protection capability of recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) from bleeding in patients with hemophilia A and B.
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The studies compared the pharmacokinetic activity of rFVIIIFc for hemophilia A and rFIXFc for hemophilia B to existing standard therapies.
Data from phase 3 registrational studies demonstrated that recombinant Fc fusion proteins have potential to protect for a long time from bleeding with fewer injections compared to standard therapies for hemophilia patients.
Biogen hemophilia therapeutic area chief medical officer and global medical affairs senior vice president Glenn Pierce said, "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."
In the A-LONG study, hemophilia A patients used once to twice weekly prophylactic rFVIIIFc injections to maintain low bleeding rates.
In the B-LONG study hemophilia B patients used one to two weeks rFIXFc prophylactic injections and maintained low bleeding rates.
The companies applied Fc fusion technology in the development of recombinant FVIIIFc and recombinant FIXFc.