DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) presented additional efficacy and safety data from the Phase III pivotal study of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)]. The new data expand on the previously disclosed topline results from the pivotal trial, which found that BAX 855 met the study's primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis.
Baxter reported that, patients in the twice-weekly prophylaxis arm of the trial experienced a 95 percent reduction in median annualized bleed rate as compared to those in the on-demand arm. The company said the study findings supported Baxter's December 2014 submission for approval of BAX 855 to the FDA.
Copyright RTT News/dpa-AFX