FDA Expands Bleeding Prevention Use for Wilate
The Food and Drug Administration (FDA) has approved a new indication for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]; Octapharma) for the prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients.
The FDA approval is based on a global, prospective, open-label, single-arm, uncontrolled, multi-center Phase 3 clinical trial in nine U.S. hemophilia treatment centers. The trial observed 28 patients with Type 1, Type 2, and Type 3 VWD who underwent 30 surgeries and 280 infusions. Treatment with Wilate was 100% successful in minor surgeries and in surgeries for Type 3 patients, and 95.2% successful in major surgeries. The overall efficacy rate of Wilate was 96.7% for surgical procedures.
Wilate is a plasma-derived, highly purified concentrate of freeze-dried human von Willebrand factor and coagulation factor VIII, already approved for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD and in patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
Wilate is available in 450 IU/5mL and 900 IU/10mL strength vials as powder for IV injection.
For more information call (866) 766-4860 or visit WilateUSA.com.