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US FDA approves expanded use of Sarepta's Duchenne gene therapy
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US FDA approves expanded use of Sarepta's Duchenne gene therapy
Jun 20, 2024 3:00 PM

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

Administration allowed the expanded use of Sarepta Therapeutics' ( SRPT )

gene therapy for all patients with Duchenne muscular

dystrophy aged four and above on Thursday.

The agency gave traditional approval to patients four

years and above who can walk, as well as accelerated approval

for those who cannot. The company, however, added that the

therapy, Elevidys, should not be used in patients with certain

mutations in the DMD gene.

The FDA gave accelerated approval to the therapy - the

first of its kind for DMD in patients between four and five

years who can walk - in June last year. Accelerated approval is

a process that allows the agency to greenlight treatments before

confirmatory data shows they work.

Continued approval for the use of the therapy in Duchenne

patients who cannot walk may be contingent on the verification

of clinical benefit in a confirmatory trial.

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