Shots:
- Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26
- Approval 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 24wks. of treatment, plus showed favorable safety & tolerability in pts
- Agamree binds the glucocorticoid receptor while modifying downstream signaling and is not a substrate for 11β-HSD enzymes
Ref: Santhera Pharmaceuticals | Image: Santhera Pharmaceuticals | Press Release
Related News: Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy
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