Like its competitor drisapersen, Sarepta Therapeutics Inc.'s eteplirsen will not enter its advisory committee meeting brimming with optimism for approval after FDA reviewers identified significant efficacy problems.
Duchenne Muscular Dystrophy: Second Product Isn't The Charm
FDA reviewers say patients treated with Sarepta's eteplirsen seemed to follow similar disease course as Duchenne muscular dystrophy natural history, casting doubts on product's approvability.
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