Friday, the FDA accepted and filed Sarepta Therapeutics Inc’s (NASDAQ:SRPT) efficacy supplement to the Biologics License Application (BLA) for Elevidys (delandistrogene moxeparvovec-rokl).
The goals of the Efficacy Supplement are twofold:
- To expand the labeled indication for Elevidys as follows: “[Elevidys is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene.”
- To convert the Elevidys accelerated approval to a traditional approval.
The FDA has granted the Efficacy Supplement a Priority Review with a review goal date of June 21, 2024. The FDA also confirmed they are not planning to hold an advisory committee meeting to discuss the supplement.
“We are pleased to announce that FDA has accepted and filed Sarepta’s ...
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