Sarepta Submits DMD Drug for FDA Approval Review

CAMBRIDGE, Mass. (TheStreet) -- Sarepta Therapeutics (SRPT) completed the submission of a new drug application to U.S. regulators seeking the approval of eteplirsen for the treatment of patients with Duchenne muscular dystrophy, or DMD, the company announced Monday.

Getting eteplirsen filed with the U.S. Food and Drug Administration in the middle of the year, as promised, allows new Sarepta CEO Ed Kaye to put a check mark next to a hugely important item on the company's to-do list. Sarepta still has a lot to get done, but eteplirsen is now on track for an FDA approval decision in the first quarter of next year.

Sarepta is just two months behind rival BioMarin Pharmaceuticals (BMRN), which submitted its competing DMD drug drisapersen to the FDA at the end of April. The BioMarin FDA filing includes results from a failed phase III study re-analyzed to show a drisapersen benefit for a subset of enrolled DMD patients.

On Monday, BioMarin announced the FDA acceptance of the drisapersen filing under priority review. The FDA approval decision date for drisapersen is Dec. 27. 

The FDA is expected to convene a panel of outside experts in the fourth quarter to review the Sarepta and BioMarin drugs and offer guidance to the agency on whether or not the drugs deserve to be approved. An official announcement of an FDA advisory panel covering the DMD drugs has not yet been made but will likely come relatively soon after the agency accepts Sarepta's eteplirsen filing in 60 days.

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