Santhera Wins Health Canada Approval For AGAMREE (Vamorolone) As First-Ever Treatment For Duchenne Muscular Dystrophy In Patients Aged 4+

Santhera Pharmaceuticals announced that Health Canada has granted approval for AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four years and older. The approval, which followed a Priority Review, makes AGAMREE the first treatment authorized in Canada for this rare and debilitating disease. According to the Canadian Neuromuscular Disease Registry, more than 800 boys and young men are currently living with DMD in the country.

Under an agreement signed in July 2024, Kye Pharmaceuticals holds exclusive commercial rights to AGAMREE in Canada for DMD and potentially other indications. The rights were secured through a sub-license with Santhera’s commercialization partner, Catalyst Pharmaceuticals, Inc. 

Santhera will receive royalties from Canadian sales, and these revenues will also contribute to North American sales milestones payable to Santhera from Catalyst. This Canadian approval marks the sixth independent regulatory authorization for AGAMREE by a local health authority, following prior positive decisions in the United States, Europe, the United Kingdom, China, and Hong Kong.