Kye Pharmaceuticals announced that Health Canada has approved AGAMREE (vamorolone) for the treatment of Duchenne Muscular Dystrophy (DMD) in boys age 4 and older. This approval – granted under Health Canada’s Priority Review process – marks an important milestone making AGAMREE the first treatment in Canada approved for DMD a muscle wasting disease that affects predominantly young boys. – Read More: What is Agamree –
Given the significant unmet need of individuals with DMD, I am pleased that AGAMREE received priority review and is now approved by Health Canada. As AGAMREE has no impact on linear growth and showed favorable changes in serum bone turnover biomarkers, it provides families with a viable treatment option compared toother corticosteroids,” says Dr. Jean Mah, Director of the Pediatric Neuromuscular Program at the Alberta Children’s Hospital in Calgary.
The Health Canada approval of AGAMREE was based on the data from the pivotal Phase 2b VISION-DMD study as supplemented with safety information collected from four open-label studies, including extension studies. In these trials, AGAMREE was administered at doses ranging from 2 to 6 mg/kg/day, extending for a period of up to 48 months. Compared with current standard of care corticosteroids, this novel corticosteroid treatment exhibited comparable efficacy, with data suggesting a reduction in adverse events, notably related to bone health, growth trajectory and behavior.
In Which Countries Is AGAMREE (vamorolone) Approved?
AGAMREE is approved in the US, EU, UK, and China. AGAMREE was licensed from Santhera Pharmaceuticals to Catalyst Pharmaceuticals, Inc. for North America. In July 2024, Kye Pharmaceuticals entered into an agreement to sublicense from Catalyst the rights to commercialize AGAMREE in Canada.
Read More: Clinical Trials for Duchenne (List of All Researches)
