FDA Approves Vonvendi for von Willebrand Disease
The Food and Drug Administration (FDA) has approved Vonvendi — von Willebrand factor (recombinant) — for on-demand treatment and control of bleeding episodes in adults age ≥18 years with von Willebrand disease (VWD). Vonvendi is the first approved recombinant von Willebrand factor for this condition.
The safety and efficacy of Vonvendi was studied in 2 trials (n=69) that enrolled adults with VWD. Data showed treatment with Vonvendi was safe and effective for on-demand treatment and control of bleeding episodes. This was tested on various sites in the body. The study reported no safety concerns during the trials. Generalized pruritus was the most commonly observed adverse reaction.
Vonvendi was granted Orphan Product designation for these indications.For more information call (800) 423-2090 or visit Baxalta.com.