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# FDA Probes New Death of Boy Who Got Elevidys
- URL: https://www.fdaweb.com/fda-probes-new-death-of-boy-who-got-elevidys/
- Published: 2025-07-28T12:00:00.000Z
- Updated: 2026-09-14T15:17:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159576

FDA is investigating another death of a young boy who received Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy. The death of the eight-year-old occurred on 6/7\. The company recently complied with an FDA request to suspend the product’s distribution as it investigates ongoing safety concerns ([see earlier story](https://www.fdaweb.com/fda-to-demand-new-elevidys-safety-data-from-sarepta/)). 

Sarepta is disputing the agency’s characterization of the patient death, claiming it was unrelated to treatment with Elevidys. Marketing partner Roche, who handles sales outside of the U.S., reported the death as occurring in Brazil and unrelated to the treatment*.*

Other media reports indicate that Brazilian authorities have ruled the death was likely a case of serious influenza A infection intensified by immunosuppression. The country’s health regulators have suspended Elevidys’s use as a precautionary measure.