For Immediate release – December 19, 2018
Recommendations provided by the Institut national d’excellence en santé et en services sociaux (INESSS), the regulating body in Quebec, have resulted in the approval of SPINRAZA (nusinersen) for Spinal Muscular Atrophy (SMA) Types 1, 2 and 3 patients in that province.
This decision is the result of a refiling of the drug approval by Biogen early in 2018, after being reviewed and approved for use in Type 1 patients only.
The effectiveness of SPINRAZA was established in the pivotal ENDEAR and CHERISH studies and supported by multiple clinical studies. For individuals with infantile-onset (Type 1) and presymptomatic SMA results showed marked improvements in muscle function. How spinraza works
“Muscular Dystrophy Canada (MDC) was pleased to support both the initial and subsequent reviews by providing a comprehensive patient submission. Ensuring our community has a strong and credible voice in all matters related to trials and treatments is at the forefront of our work in Canada,” commented Muscular Dystrophy Canada CEO, Barbara Stead-Coyle. “This is a life changing treatment for our SMA community. We applaud the Minister of Health and Social Services Danielle McCann, and the Quebec government for reconsidering their initial decision and expanding access for more clients in Quebec.”
Stead-Coyle added “MDC’s commitment to ensuring SMA clients can access this treatment at an affordable price remains steadfast. There is still much work to do and we will continue to work tirelessly to ensure that all patients who may benefit from Spinraza will receive access as quickly as possible in Canada.”
A review from the Canadian Agency for Drugs and Technologies in Health (CADTH), the regulating body for the rest of Canada, is expected in the new year.
Muscular Dystrophy Canada’s mission is to enhance the lives of those affected with neuromuscular disorders by continually working to provide ongoing support and resources while relentlessly searching for a cure through well-funded research. To learn more about Muscular Dystrophy Canada, please visit www.muscle.ca or call our toll-free number at 1-800-567-2873.
Muscular Dystrophy Canada