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# FDA Extends Review of Controversial Sarepta NDA on Eteplirsen
- URL: https://www.fdaweb.com/fda-extends-review-of-controversial-sarepta-nda-on-eteplirsen/
- Published: 2016-05-25T12:00:00.000Z
- Updated: 2026-09-14T21:05:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135766

FDA has extended its review of a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy. The submission has become a politically charged issue, with U.S. lawmakers weighing in and urging the agency to exercise its flexibilities when making a review decision. The agency notified the company that it will not be able to render a decision by the 5/25 user fee target date. “The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible,” Sarepta says. Investors saw the review extension as a positive sign. Sarepta’s stock price was up 16% in mid-morning trading. Last month, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7 to 6 ([see story](https://www.fdaweb.com/fda-panel-split-vote-not-encouraging-for-duchenne-drug/)) that a Sarepta Therapeutics NDA did not provide substantial evidence from adequate and well controlled studies that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit in Duchenne patients. The vote was seen as a setback for the company’s bid to gain accelerated approval for the drug. A separate 7 to 3 vote by the panel recommended that data were not sufficient to meet traditional approval standards.