SOBI and Biogen release positive interim results of Alprolix extension trial

Swedish Orphan Biovitrum (STO: SOBI) and its partner Biogen (Nasdaq: BIIB) have released interim results supporting the long-term safety and efficacy of Alprolix (rFIXFc) in people with severe hemophilia B, treated for up to two years.

Participants in the Phase III open-label long-term study maintained low bleeding rates with one to two week prophylaxis regimes, and no inhibitors have been reported to date. B-YOND is an ongoing extension study for people with severe hemophilia B, who completed the Phase III B-LONG or Kids B-Long pivotal studies. The primary endpoint is inhibitor development.

Birgitte Volck, chief medical officer at SOBI, said: "B-YOND represents the most extensive longterm clinical data set for a long-acting replacement FIX product. These interim results support the efficacy and safety profile of Alprolix in pediatric patients as well as in adults and adolescents.”