In a 138-patient Phase 3 clinical trial evaluating the safety and efficacy of Baxter International's (BAX +0.9%) BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A, the product candidate met its primary endpoint of reducing annualized bleed rates (ABR) in the prophylaxis arm versus the on-demand arm.
Patients in the twice-weekly prophylaxis arm experienced a 95% reduction in median ABR compared to the on-demand group (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes considering that 96% were controlled with one or two infusions.
The half life of BAX 855 was 1.4x - 1.5x that of Advate [antihemophilic factor (recombinant)].
The company expects to submit its BLA for BAX 855 before the end of 2014.