In reversal, Sarepta to face FDA’s panel of outside experts on Duchenne gene therapy
Sarepta now will have a public hearing with the FDA’s panel of outside experts on its Duchenne muscular dystrophy gene therapy, it said Thursday afternoon. The announcement comes just two weeks after Sarepta said the FDA told the company it had no plans for an advisory committee meeting.
A date has not been set for the adcomm meeting, but it will be held sometime before the FDA’s deadline of May 29 to decide whether or not to grant the therapy accelerated approval. In an investor call, Sarepta CEO Doug Ingram emphasized that the decision was not related to any new data or analysis.
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