Elevidys was approved after intense debate at the FDA, as officials and reviewers disagreed over how strong the evidence was and whether it warranted making the drug available for patients facing a fatal disease with few other options.

A patient has died while receiving Elevidys, a gene therapy for Duchenne muscular dystrophy, marking the first known death linked to the treatment. The company behind the drug, Sarepta Therapeutics, said that the patient suffered acute liver injury,

A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.