PDUFA Extension for the FDA's Review of Eteplirsen

Sarepta Therapeutics received notification of a PDUFA extension for the FDA's review of eteplirsen. The PDUFA date was extended by an extension period of three months to May 26, 2016. While this extension is frustrating – because as we all know, time is precious in Duchenne – we are hopeful that this extension will mean that the company can continue to provide the agency with additional evidence of eteplirsen's effectiveness so that this Spring brings with it an approval.

There's still no word on a new Ad Comm date, but last week PPMD and the coalition of organizations working together on this Ad Comm sent a letter requesting an update from the FDA on the rescheduled meeting. We will continue to push for a new date and will keep the community posted.

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