Canadian pharmaceutical company Kye Pharmaceuticals announced on Thursday 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 – makes AGAMREE the first treatment in Canada approved for DMD, a muscle wasting disease that affects predominantly young boys.

Health Canada's 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 behaviour.

AGAMREE is also approved in the US, EU, UK, and China. AGAMREE was licensed from Santhera Pharmaceuticals to Catalyst Pharmaceuticals Inc for North America, and in July 2024 Kye Pharmaceuticals entered into an agreement to sublicense from Catalyst the rights to commercialise AGAMREE in Canada.