Regulatory Decision Summary for WILATE
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The main purpose of this SNDS submission is to expand the surgical indication for the von Willebrand disease (VWD) from minor surgical procedures only to include all types of surgeries in adult and pediatric VWD patients.
Why was the decision issued?
The efficacy and safety of Wilate for major surgical procedures were evaluated in one multicenter, open-label, clinical trial (Study WIL-24). A total of 21 major surgical procedures were included in the study; 17 of them were in VWD type 3 patients and 2 of them were <18 years of age.
Based on the pre-defined assessment criteria, the efficacy of Wilate treatment in 18/21 (85.7%) procedures was assessed as "excellent/good" for intra- and post-operative assessment. The efficacy of only 3/21 (14.3%) procedures was assessed as "moderate". In general, the hemostatic efficacy of Wilate in preventing excessive operative bleeding can be considered satisfactory.
However, the available efficacy data related to the surgical indication in pediatric population are limited. Currently, a total of 5 major surgical procedures (2 in Study WIL-24 and 3 in Study WIL-14) in pediatric patients have been evaluated in the clinical trials. Such a limitation is reflected in the Product Monograph.
Overall, the benefit/risk analysis is favourable to expand the indication of Wilate to all types of surgeries.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations