FDAs internal disagreement over the adequacy of Sarepta Therapeutics Inc.'s efficacy evidence for Exondys 51 (eteplirsen) evolved into a debate over the intent, utility and future of the accelerated approval regulatory pathway.
Office of Drug Evaluation I Director Ellis Unger and others within the agency worried that granting eteplirsen accelerated approval for Duchenne muscular dystrophy would lower the efficacy bar for drugs approved under the pathway, eliminate the incentive for companies to invest in high-quality
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