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Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots:Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26Approval was based on pivotal P-IIb (VISION-DMD) data and EMA assessments, granting 15-year Swiss orphan drug exclusivity; Santhera retains exclusive Swiss distribution. Trial met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at…

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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 reviewApproval 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 ptsKye Pharma secured exclusive Canadian rights…

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