Elevidys (delandistrogene moxeparvovec)
OrphanATMP
- Region
- 🇪🇺 EU
- Active substance
- delandistrogene moxeparvovec
- Company
- Roche Registration GmbH
- Status
- Refused
- Therapeutic area
- Muscular Dystrophy, Duchenne
- CHMP opinion
- Thu 24 Jul 2025
- Designations
- Orphan, ATMP
- Application
- EMEA/H/C/005293
- ATC
- M09AX15
- Official record
- www.ema.europa.eu
Indication
Treatment of ambulatory patients aged 3 to 7 years old with Duchenne muscular dystrophy
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.