The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for VONVENDI®, which expands its indication to include prophylaxis use to reduce the frequency of bleeding episodes in adults with von Willebrand disease (VWD), including those with type 1 and 2 disease, and for on-demand and perioperative management of bleeding in pediatric patients with VWD.
VONVENDI is a recombinant von Willebrand factor (VWF) replacement therapy that was already FDA 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. Type 3 is the rarest and most severe form of VWD. Read the full prescribing information.
“The FDA's approval of VONVENDI for routine prophylactic use in adults with all VWD types marks a pivotal milestone in advancing care for this challenging condition. Prophylactic treatment is critical to reduce the frequency of bleeds in adults, including spontaneous and joint bleeds,” said Jonathan C. Roberts, MD, associate medical and research director at the Bleeding and Clotting Disorders Institute, associate professor of pediatrics and medicine at the University of Illinois College of Medicine at Peoria, and an investigator in the VONVENDI prophylaxis study. Dr. Roberts added that, “establishing prophylaxis as the standard of care for all adults with VWD, regardless of subtype, represents a significant step forward in helping to manage bleeding risk and the burdens that bleeds can have on patients’ daily lives.”
Source: Takeda Pharmaceuticals press release dated September 5, 2025
