> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# sBLA for Elevidys Conversion to Traditional Approval
- URL: https://www.fdaweb.com/sbla-for-elevidys-conversion-to-traditional-approval/
- Published: 2024-02-16T12:00:00.000Z
- Updated: 2026-09-14T14:23:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156378

FDA has accepted for priority review a Sarepta Therapeutics supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to convert the earlier accelerated approval to a traditional approval, and to expand the labeled indication for treating Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene. The agency has set a user fee review action target date of 6/21.

Elevidys is a single-dose, adeno-associated virus-based gene transfer therapy for intravenous infusion designed to address the underlying DMD genetic cause. The therapy has been evaluated in four clinical studies: SRP-9001-101, SRP-9001-102, SRP-9001-103 (ENDEAVOR) and SRP-9001-301 (EMBARK), according to the company. “Accelerated approval of Elevidys was primarily based on data from SRP-9001-102 and SRP-9001-103,” it says, adding that the EMBARK study served as the postmarketing confirmatory trial.