Octapharma USA: FDA Approves WILATE® License Supplement – Perioperative Management of Bleeding in Patients with von Willebrand Disease
Date: August 13, 2015
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 3 clinical study, the overall efficacy rate of Wilate treatment for surgical procedures was 96.7 percent. The 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 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 post-operative 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. Octapharma is committed to providing life saving and enhancing therapeutic options for the bleeding disorders community."