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US FDA allows expanded use of Sarepta's Duchenne gene therapy
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US FDA allows expanded use of Sarepta's Duchenne gene therapy
Jun 20, 2024 2:30 PM

June 20 (Reuters) - The U.S. Food and Drug

Administration on Thursday granted traditional approval to

Sarepta Therapeutics' ( SRPT ) gene therapy for all patients

four years and above with Duchenne muscular dystrophy (DMD) who

can walk.

The FDA in June last year approved the therapy - the

first of its kind for DMD - under its accelerated approval

process, which allows the agency to greenlight treatments before

confirmatory data shows that they work.

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