Baxter announced positive results from its Phase 3 trial of BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A. BAX 855 was developed based on Advate (Antihemophilic Factor VIII (recombinant), a FDA-approved treatment for patients with Hemophilia A to control and prevent hemorrhagic episodes; and for perioperative management, and routine prophylaxis to prevent or reduce the frequency of hemorrhagic episodes.
The multi-center, open-label study evaluated BAX 855 in 138 adolescent and adult patients with previously-treated hemophilia A. Patients received treatment twice weekly or on-demand, and were followed for six months. The primary objective of the study was the reduction in annualized bleed rates (ABR) during the treatment period compared to on-demand treatment.
Results demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in the 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.
Baxter plans to submit a Biologics License Application (BLA) for BAX 855 to the FDA before the end of 2014. A Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A is also being launched.
For more information call (800) 422-9837 or visit Baxter.com.