In December 2010, Biogen Idec and Swedish Orphan Biovitrum announced that the first patient had received the initial treatment of the companies’ long-lasting recombinant factor VIII Fc fusion protein (rFVIIIFc).
The global clinical trial, known as A-LONG, is a multicenter phase 2/3 study designed to evaluate the safety, pharmacokinetics (processing and duration of drug’s effect in the body) and efficacy of rFVIIIFc in previously treated patients with hemophilia A. The trial will expand to 60 centers worldwide with about 150 patients, who will be divided into high-dose, low-dose and on-demand groups. The product is expected to reduce the number of weekly infusions patients require.
“Dosing the first patient in the A-LONG study is an important milestone in our progress toward developing a treatment that has the potential to make a difference for the hemophilia A community,” said Glenn Pierce, MD, PhD, Vice President and Chief Medical Officer of Biogen Idec's hemophilia therapeutic area.
Source: Biogen Idec press release dated December 6, 2010