Wilate Approved for Perioperative Management of Bleeding in VWD Patients
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved revised product labeling for Wilate (von Willebrand factor/coagulation factor VIII complex [human]) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients. Formerly, Wilate’s product label 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.
In a global multi-center Phase III clinical study, the overall efficacy rate of Wilate treatment for surgical procedures was 96.7 percent. The trial observed 28 patients with types 1, 2 and 3 VWD from 24 centers in eight countries who underwent 30 surgeries and 280 infusions. Wilate treatment was successful in 100 percent of minor surgeries and 95.2 percent of major surgeries. The success rate was 100 percent in surgical procedures for type 3 patients, the most serious form of VWD.
“Preventing excessive intra- and postoperative bleeding in pediatric and adult VWD patients is a continuing challenge,” said Octapharma USA President Flemming Nielsen. “We are extremely pleased that Wilate is now available for medical providers managing this important issue.”
