Biogen, Sobi Phase III studies support recombinant Fc fusion proteins protection capability

10th February 2013 (Last Updated February 10th, 2013 18:30)

Biogen Idec and Swedish Orphan Biovitrum (Sobi) have announced new data from Phase III registrational studies supporting recombinant Fc fusion proteins' ability to provide long-lasting protection from bleeding in patients with haemophilia A and

Biogen Idec and Swedish Orphan Biovitrum (Sobi) have announced new data from Phase III registrational studies supporting recombinant Fc fusion proteins' ability to provide long-lasting protection from bleeding in patients with haemophilia A and B.

Investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) have demonstrated the ability to protect haemophilia patients from bleeding for a longer time with fewer injections than the current standard of care.

Biogen Idec haemophilia therapeutic area chief medical officer and global medical affairs senior vice president Dr Glenn Pierce said the data from the Phase III trials supports the transformation of haemophilia treatment by offering long-lasting protection from bleeding at the same time as meaningfully reducing treatment burden associated with the disease.

"Investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) have demonstrated the ability to protect haemophilia patients from bleeding for a longer time with fewer injections than the current standard of care."

"Less frequent injections may help more people with haemophilia adhere to a preventative treatment schedule, which can help prevent the long-term health consequences associated with treating a bleed after it occurs," Pierce said.

The pharmacokinetic activity of rFVIIIFc for haemophilia A and rFIXFc for haemophilia B were compared with the currently available treatments in the studies.

In the studies, the candidates stayed active in the body for a longer time, allowing participants to prevent bleeding with less frequent injections.

Patients with haemophilia A used once to twice-weekly prophylactic rFVIIIFc injections to maintain low bleeding rates in the A-LONG study.

In the B-LONG study, haemophilia B patients used prophylactic rFIXFc injections every one to two weeks with low bleeding rates.