Baxter announced that the FDA has approved Advate (antihemophilic Factor VIII [recombinant]) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A. This approval was based on a Phase 4 multicenter, open-label, prospective, randomized, controlled, prophylaxis study demonstrating that Advate for routine prophylaxis significantly reduced the median annual bleed rates (ABR) in hemophilia A patients from 44 to one as compared to an on-demand regimen, a 98% reduction in annual bleed rate (P<0.0001). Forty-two percent of study patients experienced zero bleeds during one year on prophylaxis.
Two prophylactic regimens have been approved: standard prophylaxis (20–40 IU/kg every 48 hours) and pharmacokinetic-driven prophylaxis (20–80 IU/kg every 72 hours, targeted to maintain FVIII trough levels at least 1% or higher).
Advate was initially approved in 2003 for the control and prevention of bleeding episodes in adults and children with hemophilia A.
For more information, call 866-424-6724 or visit www.advate.com.