BAX111 BLA Submitted for von Willebrand Disease
Baxter announced that it has submitted a biologics license application (BLA) to the Food and Drug Administration (FDA) for BAX111, the first recombinant von Willebrand Factor (rVWF) for patients with von Willebrand disease.
The BLA filing was based on the completion of a Phase 3 multi-center, open-label clinical trial assessing the safety, efficacy, and pharmacokinetics of BA 111. The study achieved the primary endpoint of the number of patients with treatment success for control of bleeding episodes. Patients in the full analysis set (n=22) achieved a 100% treatment success rating based on a four-point efficacy rating scale, which compared the estimated number of infusions needed to treat the bleeding episodes to the actual number of infusions administered. The median number of infusions required to treat bleeding events in the trial was one.
BAX111 has been granted orphan drug designation previously. Baxter plans to publish additional clinical data from the trial in the near future.
For more information call (800) 422-9837 or visit Baxter.com.