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# Sarepta to Submit Amondys 45 and Vyondys 53 sNDAs
- URL: https://www.fdaweb.com/sarepta-to-submit-amondys-45-and-vyondys-53-sndas/
- Published: 2026-03-19T12:00:00.000Z
- Updated: 2026-09-14T13:35:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160847

Sarepta says it will submit to FDA by the end of April sNDAs to convert the accelerated approvals of its Duchenne muscular dystrophy drugs Amondys 45 (casimersen) and Vyondys 53 (golodirsen) to traditional approvals. A company [statement](https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-provides-regulatory-update-amondys-45r-and-vyondys-53r?ref=fdaweb.com) says the decision to submit the sNDAs follows a meeting with FDA on converting the approvals.

Sarepta says its request is supported by data from the ESSENCE confirmatory study, substantial published real-world evidence supporting treatment, and the favorable safety profiles of both therapies. "Topline results from ESSENCE [presented](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestorrelations.sarepta.com%2Fstatic-files%2F0c18bee2-a0d3-41e7-b0d3-3d9b90b9129b&esheet=54455141&newsitemid=20260319684949&lan=en-US&anchor=presented&index=1&md5=6ca9d40125dadc402c55af6238b30f83&ref=fdaweb.com) at 2026 Muscular Dystrophy Association Clinical & Scientific Congress found that numerical trends favored treatment versus placebo; however, the observed difference of 0.06 steps/second in least square means (LSM), did not reach statistical significance (P=0.309) on the primary endpoint, the 4-step ascend velocity at 96 weeks," it notes.

“Sarepta has received feedback from the agency confirming that we can submit our data from ESSENCE and real-world evidence as part of the sNDAs,” the statement says. “The adequacy of the data to support conversion to traditional approval will be a matter of review.”

Amondys 45 and Vyondys 53 are described as exon-skipping therapies approved under FDA’s accelerated approval pathway for patients with Duchenne muscular dystrophy who have mutations amenable to exon 45 and exon 53 skipping, respectively.