WASHINGTON, D.C. (WDNews) — The U.S. Food and Drug Administration has expanded approval of Vonvendi, a recombinant von Willebrand factor, to include routine preventative use for adults with all types of von Willebrand disease (VWD). The approval also allows the treatment of bleeding episodes and surgical use in children with the disorder.
Vonvendi was previously limited to on-demand treatment and surgical use in adults, as well as preventative use only in adults with Type 3 VWD, the most severe form. With this decision, Vonvendi becomes the first recombinant von Willebrand factor product approved for pediatric patients in the United States.
Von Willebrand disease is a rare bleeding disorder in which the blood does not clot properly due to missing or malfunctioning von Willebrand factor. The FDA said clinical studies showed Vonvendi to be effective in managing bleeding episodes, perioperative treatment, and prevention of bleeding in adults.
The agency noted the expanded use was granted under Priority Review and with Orphan Drug Designation. Reported side effects in trials included headache, nausea, vomiting, dizziness and itching.
Vonvendi is manufactured by Takeda and remains the only recombinant von Willebrand factor therapy available in the U.S.
