FDA approves revised labelling for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex) for von Willebrand disease- Octapharma

The FDA has approved revised product labeling for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex), from Octapharma, to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients. The newly approved product label expands the FDA license for Wilate, which formerly included only the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

The overall efficacy rate of Wilate treatment for surgical procedures was 96.7% in a global, prospective, open-label, single-arm, uncontrolled, multi-center Phase III clinical study, which included nine US hemophilia treatment centers. The clinical trial observed 28 patients with Type 1, Type 2 and Type 3 VWD from 24 centers in eight countries who underwent 30 surgeries and 280 infusions. Wilate treatment was successful in 100% of minor surgeries and 95.2% of major surgeries. The study reported a 100% success rate in surgical procedures for Type 3 patients, the most serious form of VWD.