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

• Package Insert - ELEVIDYS

Supporting Documents

• June 22, 2023 Approval Letter - ELEVIDYS
• June 21, 2023 Summary Basis for Regulatory Action - ELEVIDYS
• Center Director Decisional Memo - ELEVIDYS