Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy
Shots:
- Health Canada has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy under priority review
- Approval was based on VISION-DMD study, which met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at 24wks. of treatment, plus showed favorable safety & tolerability in pts
- Kye Pharma secured exclusive Canadian rights to Agamree for DMD & other potential uses via a Jul 2024 sub-licensing deal with Catalyst Pharmaceutical, Santhera’s partner, with Santhera earning royalties on Canadian sales, contributing to North American milestones
Ref: Jazz & Genentech | Image: Jazz Pharmaceuticals| Press Release
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