Sarepta Therapeutics, Inc.’s prediction of a four-month lag in commercial access to its gene therapy SRP-9001 (delandistrogene moxeparvovec) helped sway a US Food and Drug Administration panel vote in favor of accelerated approval for the Duchenne muscular dystrophy treatment.
Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says
Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.
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