Date: June 20, 2025
Attention: Providers
URGENT PATIENT SAFETY NOTICE: Sarepta suspends the drug, ELEVIDYS (HCPCS code J1413) for Non-ambulatory patients with Duchene muscular dystrophy due to patient safety concerns including risk for acute liver failure and death. Providers should halt the administration of ELEVIDYS for non-ambulatory clients while an enhanced immunosuppressive regimen is evaluated. |
Press release: Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
Additional information: ELEVIDYS (Delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory and non-ambulatory individuals who are four years or older with Duchenne muscular dystrophy (DMD) and have a confirmed mutation in the DMD gene. Sarepta is suspending shipments of ELEVIDYS for non-ambulatory clients.
Next step for Providers: Non-ambulatory members initially approved for Elevidys should stop taking the drug until more information is known about how to prevent this. Texas Children’s Health Plan will publish more information as it becomes available at www.texaschildrenshealthplan.org/provideralerts. Additionally, providers can reference Texas Medicaid and Healthcare Partnership for updates under Recent News.
If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.
For access to all provider alerts: www.texaschildrenshealthplan.org/provideralerts.