Sarepta Therapeutics, Inc. (SRPT), Monday announced that FDA said additional data are required as part of the New Drug Application or NDA submission for Eteplirsen, including the results from an independent assessment of dystrophin images and the 168-week clinical data from study 202. Also, FDA asked for more specific data, including a minimum duration of safety in new patients exposed to eteplirsen, patient-level natural history data and MRI data from a recent study conducted by an independent academic group.
Based on these requests, the company plans to file an NDA by mid-year 2015, pending any additional requests from further discussions with the FDA.
The FDA said further talks with Sarepta will be required to determine what would constitute a complete NDA.
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