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 H2’26 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…

ByDipanshu DixitJanuary 15, 2026

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Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

S Shots: Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…

ByPrince GiriJune 30, 2025

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

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

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