FDA approves Advate (Baxter) for prophylaxis of Hemophilia A

The FDA has approved Advate [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] from Baxter for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with Hemophilia A. Advate is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children. The approval is based on a Phase IV prophylaxis study sponsored by Baxter demonstrating that Advate for routine prophylaxis significantly reduced median annual bleed rates (ABR) in hemophilia A patients from 44 to one as compared to an on-demand regimen. Forty-two percent of study patients experienced zero bleeds during one year on prophylaxis.