Shots:
- Japan’s MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 Abs
- Approval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was shared at MDA 2025, with Part 1 full data published in the Nature Medicine & quantitative muscle MR data published in the JAMA Neurology
- As per the 2019 collaboration with Roche, Sarepta will receive ~$103.5M in near-term regulatory & commercial milestones; commercialization of Elevidys in Japan is via Chugai Pharmaceuticals under its alliance with Roche
Ref: Sarepta Therapeutics | Image: Sarepta Therapeutics | Press Release
Related News:- Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
