India Pharma Outlook Team | Monday, 08 September 2025
Takeda got an approval from the U.S. Food and Drug Administration (FDA) for the additional Biologics License Application (BLA) for VONVENDI [von Willebrand factor (Recombinant)]. The gained permission stretches its application to regular prophylaxis for the purpose of lessening bleeding events in adult patients with von Willebrand Disease (VWD), apart from on-demand and perioperative management in both adult and pediatric patients.
It was only good for on-demand and perioperative treatment in adults with severe Type 3 VWD before VONVENDI is now staggeringly better across a wider patient population, including children. VWD, the most common inherited bleeding disorder, is responsible for more than three million people in the U.S. and affects men and women equally. The disorder is due to the low level or malfunction of VWF, a protein which is necessary for blood clotting, therefore the symptoms may be persistent bleeding, frequent nosebleeds, heavy menstrual bleeding, bleeding in the gastrointestinal tract, and other complications after surgery or childbirth.
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VONVENDI as a recombinant VWF replacement has the nature of a long half-life, which is 22.6 hours in adults and 14.3 hours in children. Research conducted on patients shows that it is generally possible to cover one bleeding episode with a single application of a drug.
FDA was backingly supported by three clinical trials including phase 3 studies in adults and children with VWD. Experts give the opinion that preventative therapy is the one which significantly limits spontaneous and joint bleeds as well, the patients; daily quality of life is promoted.
