Octapharma Submits Wilate sBLA

Octapharma USA has submitted an sBLA to FDA to expand the approval of Wilate (von Willebrand factor/coagulation factor VIII complex [human] lyophilized powder for solution for intravenous injection) to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease (VWD). The company says the sBLA is supported by the results of the Phase 3 WIL-31 study that investigated the efficacy and safety of Wilate prophylaxis over 12 months in people aged six and older with severe VWD of any type except type 2N.

Wilate is currently indicated in children and adults with VWD for on-demand treatment and control of bleeding episodes and perioperative management of bleeding, Octapharma says. It also is indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes.