Posted by Michael Wonder on 03 Oct 2025
Health Canada approves Agamree (vamorolone) as the first treatment for Duchenne muscular dystrophy in Canada
2 October 2025 - Kye Pharmaceuticals announced today that Health Canada has approved Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy 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 Duchenne muscular dystrophy a muscle wasting disease that affects predominantly young boys.
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.
