Sarepta Lashed Again; More Duchenne Market Doubt
This article was originally published in Scrip
The FDA has appeared to be in a love-hate relationship with Sarepta Therapeutics Inc.
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At a highly charged April 25 meeting of the FDA's Peripheral and Central Nervous System (PCNS) Advisory Committee, which concluded with angry shouting from parents and patient advocates, a majority of panelists said Sarepta Therapeutics Inc. failed to provide sufficient efficacy data for its Duchenne muscular dystrophy drug eteplirsen to win US approval – accelerated or standard, although the votes were much closer on the former than on the latter question.
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