Baxter announced additional safety and efficacy data from its Phase 3 study of BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A based on Advate [Antihemophilic Factor (Recombinant)].
The prospective, global, multi-center, open-label, two-arm study evaluated BAX 855 among 137 previously treated hemophilia A patients who were ≥12 years of age. Patients were assigned either to twice weekly prophylaxis (40–50 IU/kg, n=120) or on-demand treatment (10–50 IU/kg, n=17).
The new data expands on the previously announced results from the trial, which found that BAX 855 met the study’s primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis. Patients in the twice-weekly prophylaxis arm of the trial experienced a 95% reduction in median annualized bleed rate (ABR) as compared to those in the on-demand arm (1.9 vs. 41.5, respectively).
Recent data demonstrated that BAX 855 was effective in treating bleeding episodes, 96% of which were controlled with one or two infusions at a median dose of 29.0 IU/kg per infusion. Treatment was rated excellent or good for nearly all episodes (96.2%). In the prophylactic group (n=101), 40% of patients experienced no bleeds. The study also showed that BAX 855 pharmacokinetics offered a 1.4–1.5-fold extended half-life compared to Advate with a median infusion interval of 3.6 days, supporting the findings from the Phase 1 trial.
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