In early February, Biogen Idec and Swedish Orphan Biovitrum (Sobi) released data on two investigational therapies for hemophilia: recombinant factors VIII Fc fusion protein (rFVIIIFc) and recombinant factor IX Fc fusion protein (rFIXFc). The data, drawn from global phase III studies, suggest that both drugs provide long-lasting protection from bleeding with fewer infusions than current factor products used to treat hemophilia A and B. The data were presented at the 6th Annual Congress of the European Association for Haemophilia and Allied Disorders, February 6-8, 2013, in Warsaw, Poland.
The studies, known as A-LONG and B-LONG, compared the pharmacokinetic activity of prophylactic rFVIIIFc for hemophilia A and rFIXFc for hemophilia B to currently available treatments. In the A-LONG study, rFVIIIFc was given once or twice weekly, compared to the typical thrice weekly or every other day dosing. rFIXFc was given to patients every one to two weeks, and remained active in the body longer. Both drugs had 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, MD, PhD, 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.”
Source: Biogen Idec press release dated February 8, 2013