Defeat Duchenne Canada is thrilled to share that Kye Pharmaceuticals has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of AGAMREE® (vamorolone). If approved, AGAMREE® would be the first and only treatment approved by Health Canada, specifically for Duchenne – a major step forward in the fight against Duchenne muscular dystrophy.
Health Canada has also granted this new treatment priority review, which signals an understanding of the debilitating nature of Duchenne muscular dystrophy and an acknowledgement that there are currently no treatments available in Canada that offer significant benefit to Duchenne patients. If everything goes well, the potential exists for AGAMREE® to be approved before the end of 2025.
“This moment marks a powerful stride toward change for Canadian families affected by Duchenne. AGAMREE® represents a new class of dissociative steroid therapies, designed to reduce inflammation while potentially minimizing the side effects typically associated with traditional corticosteroids. Most importantly, it offers renewed hope to our community – hope for improved strength, mobility, and quality of life for many of those living with this devastating disease.”
Lisa McCoy, Chief Executive Director of Defeat Duchenne Canada
Defeat Duchenne Canada has played a leading role in bringing AGAMREE® (vamorolone) closer to Canadian patients. In 2021, we granted $750,000 toward the launch of the VBP15-006 clinical trial, which focused on boys with Duchenne from 2 years up to less than 18 years old. This trial was uniquely conducted across six Canadian sites, and would not have been possible without the unwavering support of our donors and our Canadian families, who have and continue to dedicate their time to participating in these studies.
Health Canada’s priority review signals the urgency and promise of this treatment, and we are filled with optimism for what’s ahead. We remain dedicated to accelerating access to innovative, affordable therapies and will continue to champion every breakthrough that brings us closer to a future without Duchenne.
Want to know more about Duchenne Research?
Scientists and medical experts have been tirelessly pursuing diverse approaches to defeat Duchenne muscular dystrophy. From tackling the root cause to alleviating symptoms, the field of research is vast and promising. Explore the various strategies being developed and tested, and gain insights into the future of muscular dystrophy treatment: