ELEVIDYS

STN: 125781
Proper Name: delandistrogene moxeparvovec-rokl
Tradename: ELEVIDYS
Manufacturer: Sarepta Therapeutics, Inc.
Indication:
ELEVIDYS is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD) who are ambulatory and have a confirmed mutation in the DMD gene.

Limitations of Use:
ELEVIDYS is not recommended in patients with:

Preexisting liver impairment (defined as gamma-glutamyl transferase [GGT] > 2 x upper limitof normal or total bilirubin > the upper limit of normal not due to Gilbert’s syndrome) or activehepatic viral infection due to the high risk of acute serious liver injury and acute liver failure.
Recent vaccination (within 4 weeks of treatment) due to immunogenicity and potential safety concerns.
Active or recent (within 4 weeks) infections due to safety concerns.

Product Information

Package Insert - ELEVIDYS
Medication Guide - ELEVIDYS
Demographic Subgroup Information – delandistrogene moxeparvovec-rokl (ELEVIDYS)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

ELEVIDYS

Product Information

Latest Safety Information

Supporting Documents