US EditionFDA Expands Use of Vonvendi for Von Willebrand Disease
Vonvendi is now approved for routine prevention in adults and treatment in children with von Willebrand disease, based on multiple studies confirming its effectiveness.
- FDA regulators cleared expanded use of Vonvendi for routine prophylaxis in adults with all VWD types and on-demand and perioperative treatment in children, granting approval to Takeda.
- Previously, Vonvendi had been limited to on-demand and perioperative use in adults and preventative use only in adults with type 3 von Willebrand disease, but clinical studies showed effectiveness across ages, supporting expanded use.
- Uniquely, Vonvendi has safety data showing headache, vomiting, nausea, dizziness, and itchy skin as common adverse reactions, observed in ≥2% of clinical trial participants.
- FDA leaders framed the decision by saying Vijay Kumar, M.D., called it a testament to collaboration in pediatric and adult therapies, and Vinay Prasad, M.D., highlighted FDA's flexibility in rare disease evaluations.
- Von Willebrand disease is a bleeding disorder where patients have low levels or dysfunctional von Willebrand factor , impairing proper blood clotting.
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FDA Expands Use of Vonvendi for Von Willebrand Disease
MONDAY, Sept. 8, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved expanded use of Vonvendi (von Willebrand factor [recombinant]) for routine prophylactic use in adults with all types of the blood-clotting disorder von Willebrand disease (VWD),…
FDA expands use of Vonvendi for von Willebrand disease
The U.S. Food and Drug Administration has approved expanded use of Vonvendi (von Willebrand factor [recombinant]) for routine prophylactic use in adults with all types of the blood-clotting disorder von Willebrand disease (VWD), as well as for on-demand treatment of bleeding episodes and perioperative use in children with VWD.
FDA Expands Approval of Vonvendi for von Willebrand Disease, Including Pediatric Use
The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with...
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