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April 21, 2014
07:04 EDTSRPTSarepta plans to submit NDA for Eteplirsen by year end 2014
Sarepta plans to submit a New Drug Application to the FDA by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD. Eteplirsen is Sarepta’s lead exon-skipping drug candidate in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51. The plan is based on a guidance letter from the Agency that proposed a strategy regarding the submission of an NDA for eteplirsen under a potential Accelerated Approval pathway. Based on the Agency’s guidance, Sarepta plans to initiate several additional clinical studies with eteplirsen later this year in exon-51 amenable genotypes.
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