U.S. FDA Approves Expanded Indication for VONVENDI®

The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for VONVENDI® [von Willebrand factor (recombinant)], broadening its indications in von Willebrand disease (VWD).

Key updates include:

• Routine prophylaxis: Now approved to reduce the frequency of bleeding episodes in adults with Type 1 and Type 2 VWD.
• Pediatrics: Approved for on-demand and perioperative management of bleeding in children with VWD.
• Expanded adult use: Builds on prior approvals for on-demand and perioperative management in adults, and prophylaxis in severe Type 3 VWD.

With this decision, VONVENDI becomes the only recombinant VWF replacement therapy approved for both adults and pediatric patients across multiple VWD types.

Learn more:

Takeda News Release: U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease

FDA News Release: FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children

---