Business
U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease
OSAKA, Japan & CAMBRIDGE, Mass., September 06, 2025--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for VONVENDI® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of
![U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease](https://media.zenfs.com/en/business-wire.com/2fbd94618e416dcbf89e47a950a5adc5)
About this update from Takeda Pharmaceutical Co. Ltd.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":266,"url":"https://media.zenfs.com/en/business-wire.com/2fbd94618e416dcbf89e47a950a5adc5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/ZxA2IcNkCTqbTB3Oc5r8ew--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTUzMjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/2fbd94618e416dcbf89e47a950a5adc5","width":480,"height":266}},"lazy":false},{"type":"text","content":"− Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1","length":254,"tagName":"p"},{"type":"text","content":"− VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1","length":135,"tagName":"p"},{"type":"text","content":"− VWD, the Most Common Bleeding Disorder, Impacts More Than 3 Million People in the U.S.2","length":89,"tagName":"p"},{"type":"text","content":"OSAKA, Japan & CAMBRIDGE, Mass., September 06, 2025--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for VONVENDI® [von Willebrand factor (Recombinant)], expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and 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.1","length":741,"tagName":"p"},{"type":"text","content":"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.1","length":207,"tagName":"p"},{"type":"text","content":"VWD is the most common bleeding disorder impacting more than 3 million people in the U.S. alone. It occurs equally among men and women. People with VWD have lo...