Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure

Sarepta Therapeutics has paused all US shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, effective July 22, 2025, bowing to a direct request from the FDA after initially resisting the agency's demand123.

The suspension follows multiple patient deaths linked to Sarepta’s gene therapy products, including two deaths after Elevidys treatment and a third involving a separate investigational therapy for limb-girdle muscular dystrophy (LGMD)135.

Sarepta initially only agreed to stop shipping the therapy to non-walking patients, but reversed course and fully complied with the FDA after increased scrutiny and concern about maintaining a cooperative relationship with regulators123.

The pause will give Sarepta time to respond to FDA information requests, address any regulatory questions, and complete the process of updating Elevidys’ safety labeling23.

The suspension is voluntary and temporary, and Sarepta has indicated it may resume shipments once regulatory issues are addressed23.

The business outlook for Elevidys is now uncertain, with questions about how long the shipments will be halted and what impact this will have on sales and adoption in the DMD community2.

Sources:

1. https://www.bmj.com/content/390/bmj.r1548

2. https://www.biospace.com/business/sarepta-concedes-to-fda-request-suspends-us-shipments-of-elevidys

3. https://www.fiercepharma.com/pharma/sarepta-getting-back-fdas-good-side-pauses-shipments-duchenne-gene-therapy-elevidys

5. https://www.fiercebiotech.com/biotech/sarepta-ldmd-trials-all-hit-fda-hold-amid-newly-surfaced-safety-concerns