A Milestone in Neuromuscular Care: AGAMREE® (vamorolone) Approved as the First Treatment for Duchenne Muscular Dystrophy in Canada
Health Canada has approved AGAMREE® (vamorolone), marking the first-ever treatment for Duchenne Muscular Dystrophy (DMD) in Canada!
Granted under Health Canada’s Priority Review process, this approval represents its potential to significantly impact the lives of those affected by the debilitating disease. This is a landmark moment for families and clinicians, advancing the mission to raise the standard of care, improve access to therapies, and support those living with Duchenne across the country.
AGAMREE® is approved for boys aged 4 years and older, with no upper age limit.
The AGAMREE® Patient Support Program opens for enrollment on October 10, 2025.
“Given the significant unmet need of individuals with DMD, I am pleased that AGAMREE® has received priority review and is now approved by Health Canada. As AGAMREE® has no impact on linear growth and showed favourable changes in serum bone turnover biomarkers, it provides families with a viable treatment option compared to other corticosteroids.”
— Dr. Jean Mah, Director of the Pediatric Neuromuscular Program at the Alberta Children’s Hospital and NMD4C Investigator
“For too long, Canadian families have watched treatment advances unfold elsewhere while waiting for options here at home. With this approval, a new era of innovative therapies and treatments for Duchenne begins. This milestone is cause for celebration, while the continued focus remains on ensuring that AGAMREE® is not only approved, but also reimbursed and accessible to every Canadian who needs it.”
— Dr. Homira Osman, VP of Research & Public Policy, Muscular Dystrophy Canada & NMD4C Steering Committee Co-Chair
“This is an exciting day for Canadians and many Duchenne parents join in celebrating the very first treatment approved in Canada. It is thanks to the collaborative efforts of all who have been involved in bringing this treatment to fruition. The hope is that this is the first of many treatment options that will become available to Canadians living with Duchenne.”
— Nicola Worsfold, Executive Director, Defeat Duchenne Canada
This achievement is a testament to the power of collaboration among researchers, clinicians, families, and advocacy organizations. It reflects our collective commitment to raising the standard of care, improving access to therapies, and building research capacity across Canada.
For more details on AGAMREE®
Read the Full Announcement
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