FDA accepts Takeda's sBLA for Vonvendi

Japanese pharma major Takeda (TYO: 4502) announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Vonvendi [von Willebrand factor (Recombinant)] for investigational routine prophylactic use in adults (age 18 years and older) with von Willebrand disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative use in children with VWD.

Vonvendi is currently approved for use in adults with VWD for on-demand treatment and control of bleeding episodes, perioperative bleeding management and routine prophylactic use for patients with severe Type 3 VWD receiving on-demand therapy.

According to Takeda, Vonvendi is the only recombinant von Willebrand factor (VWF) replacement therapy. It is designed to replace the body's missing or dysfunctional VWF, which is needed to form clots as well as carry and protect coagulation factor VIII from rapid elimination.