The rFVIIIFc program is partnered with Biogen Idec.
rFVIIIFc is a fully recombinant clotting factor designed to replace the protein that hemophilia A patients lack and to last longer in the body than commercially available Factor VIII products. rFVIIIFc has been developed using monomeric Fc-fusion technology, which leverages a natural mechanism that recycles rFVIIIFc in the circulation to extend its half-life.
rFVIIIFc is the only long-lasting treatment option for hemophilia A, that is currently being evaluated in late-stage clinical trials. rFVIIIFc is being evaluated in a Phase II/III registrational, open-label, multicenter trial (A-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in the prevention and treatment of bleeding in previously treated patients with severe hemophilia A.
For more information on the rFVIIIFc trial, please visit www.clinicaltrials.gov.
rFVIIIFc news
On September 20, 2010, the European Commission granted orphan drug designation to rFVIIIFc.
On December 6, it was announced that the first patient has been treated with Sobi's and BiogenIdec's long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.
On December 23, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to rFVIIIFc.