U.S. License Holder:
Sarepta Therapeutics
Date of License:
June-22-2023
Last Update:
July-08-2024
FDA-Approved Indications
ELEVIDYS (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated in individuals at least 4 years of age:
For the treatment of Duchenne muscular dystrophy (DMD) in patients who are ambulatory and have a confirmed mutation in the DMD gene;
For the treatment of DMD in patients who are non-ambulatory and have a confirmed mutation in the DMD gene.