TOKYO (dpa-AFX) - Takeda Pharmaceutical Company Limited (TAK, TKPHF, 4502.T) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for VONVENDI [von Willebrand factor (Recombinant)]. The expanded indication now includes routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and Type 2. It also covers on-demand and perioperative management of bleeding in pediatric patients with VWD.
VONVENDI was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy.
VONVENDI is now available for use in a broad range of VWD patients and is the only recombinant von Willebrand Factor (VWF) replacement therapy with approved indications in both adults and children with VWD.
Takeda submitted applications seeking approval to expand the indications of VONVENDI for on-demand and perioperative management of bleeding in pediatric patients with VWD in Japan and VEYVONDI (vonicog alfa) for on-demand use in pediatric patients with VWD in the European Union.
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