May 10 (Reuters) - The U.S. Food and Drug
Administration's staff reviewers on Wednesday flagged concerns
that data presented for Sarepta Therapeutics' experimental gene therapy for a muscle-wasting disorder did not
strongly prove that it worked.
Sarepta is seeking accelerated approval for the first gene
therapy for Duchenne muscular dystrophy, based on data that
showed it helped patients make a mini version of the dystrophin
protein needed to keep muscle cells intact.
(Reporting by Leroy Leo in Bengaluru; Editing by Sriraj
Kalluvila)
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