ELEVIDYS
STN: 125781
Proper Name: delandistrogene moxeparvovec-rokl
Tradename: ELEVIDYS
Manufacturer: Sarepta Therapeutics, Inc.
Indication:
- For the Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
Product Information
Supporting Documents
- June 22, 2023 Approval Letter - ELEVIDYS
- June 21, 2023 Summary Basis for Regulatory Action - ELEVIDYS
- Center Director Decisional Memo - ELEVIDYS