Wilate® is now approved in Canada for Prophylaxis in Von Willebrand Disease

TORONTO, ON – February 27, 2024

Wilate® Now Approved by Health Canada for Prophylaxis Treatment of Von Willebrand Disease (VWD) in Adults and Pediatric Patients Aged 6 and Older

Octapharma Canada is pleased to announce the Canadian approval of Wilate® (von Willebrand Factor/Coagulation Factor VIII Complex (Human) for use in prophylaxis treatment of Von Willebrand Disease (VWD) in adults and pediatric patients aged 6 and older with any type of VWD.

Understanding the Problem: The Challenge of Managing VWD

Von Willebrand Disease (VWD) is a common inherited bleeding disorder that affects the blood's ability to clot properly. Patients with VWD often suffer from frequent and spontaneous bleeding episodes, which can significantly impact their quality of life. Traditional treatment methods have focused on on-demand therapy, treating bleeding episodes as they occur. However, this reactive approach often leaves patients at risk of frequent bleeds and the associated complications.

Significance of the WIL-31 Study: A Breakthrough in VWD Treatment

The Health Canada approval is supported by the WIL-31 study, the largest prospective, non-controlled, international, multicenter phase 3 trial that investigated the efficacy and safety of Wilate® prophylaxis over 12 months in people aged 6 and older with severe VWD of any type.

All WIL-31 patients had received on-demand treatment with Wilate® during a previous six-month prospective observational study (WIL-29). The primary goal of the clinical trial was to determine if prophylaxis with Wilate® could reduce the mean total annualized bleeding rate (ABR) by more than 50% compared to the six months of on-demand treatment. Secondary objectives included measuring spontaneous ABR and treatment-emergent adverse events.

The study reported an 84% reduction¹ in the mean total ABR compared to on-demand treatment during the prior study. The median spontaneous ABR decreased by 95%¹. Additionally, the study highlighted efficacy benefits across various bleeding sites for these patients. Importantly, no serious drug-related adverse events or thrombotic events were observed during the study.

Impact of Health Canada's Approval

The WIL-31 study, the largest of its kind, demonstrated that prophylactic treatment with Wilate® can significantly reduce annual bleeding rates across various patient demographics—children and adults, males and females, and across all types of VWD.

Dr. Chai Phua highlighted the positive impact of Health Canada's approval, stating,

"This approval marks a significant advancement in hematology, emphasizing the broader application of prophylaxis in Von Willebrand Disease. By preventing bleeding, we can fundamentally change how we treat patients, allowing them to live their best lives without VWD impacting their daily activities. The significance of prophylaxis in VWD management points to a paradigm shift—moving from treating bleeding events to preventing them. This approach helps improve patients’ quality of life, enabling them to engage in daily activities with less anxiety about physical activities, fewer bleeding events, less time off work, and fewer hospitalizations. All of this contributes to the enhanced quality of life that has evolved in VWD management."

A New Era for VWD Patients in Canada

With this approval, VWD patients in Canada can now look forward to a new era of prophylaxis-based care, similar to the benefits received by Hemophilia A patients. Prophylaxis treatment has been shown to significantly improve patient outcomes, reducing the frequency and severity of bleeding episodes and enhancing overall quality of life. Patients can expect fewer interruptions in their daily activities, less time spent in hospitals, and a greater sense of normalcy in their lives. This proactive approach to managing VWD represents a monumental shift in patient care, promising a brighter future for those living with this condition.

For complete prescribing information, please visit the Wilate Product Monograph.²

About wilate^®

 Wilate® is indicated for²:

• Treatment and prophylaxis of spontaneous and trauma-induced bleeds in all types of VWD in adult and pediatric patients where use of DDAVP (1-deamino-8-D-arginine vasopressin/desmopressin) treatment is ineffective or contra-indicated. 

• Prevention and treatment of bleeding during and after surgical procedures

For complete prescribing information, please visit the Wilate Product Monograph².

Media Contact: Sri Adapa
General Manager
Octapharma Canada
info.canada@octapharma.com

References:

^{1. Sidonio, R. F., Boban, A., Dubey, L., Inati, A., Kiss, C., Boda, Z., Lissitchkov, T., Nemes, L., Novik, D., Peteva, E., Taher, A. T., Timofeeva, M. A., Vilchevska, K. V., Vdovin, V., Werner, S., Knaub, S., & Khayat, C. D. (2024). von Willebrand factor/factor VIII concentrate (Wilate) prophylaxis in children and adults with von Willebrand disease. Blood Advances, 8(6), 1405–1414. https://doi.org/10.1182/bloodadvances.2s023011742}

^{2. Wilate™ Product Monograph. Feb’27, 2024.}