FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys (2)

July 26, 2025, 12:12 AM UTC

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

The death occurred on June 7, according to a statement from the US Food and Drug Administration, which did not specify where the boy lived.

On Thursday, Sarepta’s partner, Roche Holding AG, which markets the treatment outside the US, said that a patient in Brazil recently died after being treated with Elevidys for Duchenne muscular dystrophy. Brazilian authorities said that the death was unlikely to be due to the drug. The patient died of a viral infection that may have ...

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