Photo by Piotr Bodzek
The US Food and Drug Administration (FDA) has expanded the approved indication for a human von Willebrand factor/coagulation factor VIII complex (Wilate) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric patients with von Willebrand disease (VWD).
The product was previously approved for 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.
About Wilate
Wilate is a plasma-derived, highly purified concentrate of freeze-dried human von Willebrand factor and coagulation factor VIII. Two virus-inactivation steps are incorporated into the manufacturing process of the product: a solvent/detergent and terminal dry-heat treatment.
Investigators evaluated Wilate’s safety and efficacy in surgical procedures in a single-arm, phase 3 study known as WONDERS. The investigators enrolled 41 patients, 30 of whom completed the trial.
The patients had type 1, type 2 or type 3 VWD. They had a median age of 39.7, and most were female. All patients underwent surgery—21 major and 9 minor surgeries.
The hemostatic efficacy of Wilate was assessed intra-operatively by the surgeon and post-operatively by investigators. The overall hemostatic efficacy—success or failure—of Wilate was based on both assessments, using a 4-point ordinal efficacy scale.
In the 29 evaluable surgeries, the success rate was 96.7%. Wilate was successful in 100% of minor surgeries (n=9) and 95.2% of major surgeries (n=20).
There were 2 serious adverse events—erosive gastritis and vaginal hemorrhage. Nonserious events included nausea (7 cases in 6 patients), vomiting (n=6), pain (n=4), pyrexia (n=4), procedural pain (10 cases in 8 patients), decrease in hemoglobin (6 cases in 4 patients), and hypertension (n=4).
Wilate is under development by Octapharma. For more information on the product, visit www.WILATEusa.com.
