Baxter has submitted a biologics license application (BLA) to the FDA for approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A.
BAX 855 is based on ADVATE [Antihemophilic Factor (Recombinant)], Baxter’s flagship hemophilia product, which Biogen Idec is challenging with the approval of Eloctate by FDA in June.
BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older, in a prospective, global, multi-center, open-label, two-arm Phase-III study of 137 previously treated patients.
Patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported, Baxter said.
Baxter expects to file for marketing authorization with the European Medicines Agency (EMA) in 2016.