Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy
Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen. Eteplirsen is being evaluated for the treatment of Duchenne muscular dystrophy (DMD) and is designed to enable the production of a functional internally truncated dystrophin protein in patients with mutations amenable to exon 51 skipping.
The NDA submission includes a request for Priority Review. Previously the FDA had granted eteplirsen Orphan Drug and Fast Track designation for Duchenne muscular dystrophy.
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