Shares of Sarepta Therapeutics (SRPT) are up 4% in pre-market trading after the company announced it has completed its rolling submission for a New Drug Application - NDA - known as Eteplirsen. Eteplirsen is an exon skipping RNA drug that restores dystrophin levels in patients with Duchenne Muscular Dystrophy - DMD.
These restored dystrophin levels allow these patients to improve muscle movements in their bodies. Sarepta states that the final submission occurred this past Friday June 26, 2015. This package to the FDA for Eteplirsen approval also includes a request to the FDA to attempt to get priority review for the drug. Priority review would allow the company to have its DMD drug to be reviewed by a 6 month period instead of waiting 10 months.
This pushes up the timeline to about the 1st quarter of 2016 when it will be decided about Eteplirsen's approval by the FDA. Eteplirsen has already received both, Orphan status and Fast Track status as well. Orphan status will give the company special tax benefits and longer market exclusivity for its drug before the patent expire. Fast Track status will bring close and fast talks with the FDA for the DMD drug as it meets an unmet medical need. Patients need a drug that can help restore dystrophin levels for their disease, and Eteplirsen is the right drug for them.
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