Swissmedic accepts Santhera's marketing authorization application for Duchenne muscular dystrophy drug AGAMREE®.

Santhera Pharmaceuticals has received acceptance from Swissmedic for the marketing authorization application of AGAMREE® (vamorolone) to treat Duchenne muscular dystrophy (DMD). The agency will evaluate the drug based on its December 2023 EU approval, potentially expediting the process. Results from the review are anticipated by late H1-2026, or earlier if conditions are met. AGAMREE serves as a novel alternative to traditional corticosteroids.

September 24, 2024
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