ELEVIDYS

STN: 125781
Proper Name: delandistrogene moxeparvovec-rokl
Tradename: ELEVIDYS
Manufacturer: Sarepta Therapeutics, Inc.
Indication:
Ambulatory patients with Duchenne Muscular Dystrophy (DMD) at least 4 years of age who have a confirmed mutation of the DMD gene.

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.

Latest Safety Information

• FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients
  November 14, 2025
• FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS
  June 24, 2025

Supporting Documents

• November 14, 2025 Approval Letter - ELEVIDYS
• August 29, 2024 Approval Letter - ELEVIDYS
• June 20, 2024 Approval Letter - ELEVIDYS
• Center Director Decisional Memo - ELEVIDYS
• Office of Clinical Evaluation Director Memo - ELEVIDYS
• June 18, 2024 Integrated Clinical and Clinical Pharmacology Review Memo - ELEVIDYS
• Statistical Review - ELEVIDYS
• June 11, 2024 CMC Review Memo - ELEVIDYS
• January 10, 2024 Approval Letter - ELEVIDYS
• June 21, 2023 Summary Basis for Regulatory Action - ELEVIDYS
• Center Director Decisional Memo - ELEVIDYS
• Approval History, Letters, Reviews, and Related Documents - ELEVIDYS