Outside advisers to the Food and Drug Administration on Friday voted in favor of granting accelerated approval to Sarepta Therapeutics’ gene therapy to treat Duchenne muscular dystrophy.
The advisers voted 8-6 in favor of the agency granting accelerated approval.
Agency officials in the meeting criticized the evidence for the drug.
The FDA doesn’t have to agree with its advisers and is expected to make a final decision later this month.
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