Santhera Pharmaceuticals (SANN.SW) announced that it has received approval from Health Canada for AGAMREE (vamorolone) as a treatment for Duchenne muscular dystrophy (DMD) in patients aged 4 years and older. The decision followed a Priority Review process and marks a historic milestone—AGAMREE is now the first authorized therapy for DMD in Canada.
This is the sixth independent approval a by local health authority, following positive regulatory decisions in the U.S., Europe, the UK, China and Hong Kong.
Kye Pharmaceuticals holds exclusive Canadian commercial rights to AGAMREE for the treatment of DMD and potentially other indications, following the agreement of a sub-license with Santheras commercialization partner Catalyst Pharmaceuticals, Inc. in July 2024.
Santhera will receive royalties on Canadian sales and these sales will also contribute towards North American sales milestones payable to Santhera from its partner Catalyst.
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