By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. Both sides want to find a way to approve eteplirsen, which is why Monday night's announcement about a compromise solution to resolve the long-delayed clinical review is good news and a positive step.
Under the new plan, Sarepta will submit to FDA additional clinical data aimed at confirming eteplirsen's ability to produce dystrophin, the muscle-lubricating protein that is missing in patients with DMD. And these confirmatory data will be all that the FDA needs to finally grant accelerated approval to eteplirsen, noted Mr Feuerstein.
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