Trial Profile
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial for Duchenne Muscular Dystrophy Using SRP-9001
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 26 Feb 2024
Price :
$35
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At a glance
- Drugs Delandistrogene moxeparvovec (Primary)
- Indications Duchenne muscular dystrophy
- Focus Registrational; Therapeutic Use
- Sponsors Sarepta Therapeutics
- 19 Feb 2024 According to a Sarepta Therapeutics media release, FDA has granted the Efficacy Supplement a Priority Review with a review goal date of June 21, 2024. The Agency has also confirmed they are not planning to hold an advisory committee meeting to discuss the supplement.
- 19 Feb 2024 According to a Sarepta Therapeutics media release, FDA has accepted and filed Sarepta's Efficacy Supplement to evaluate broadening the approved indication of Elevidys by removing age and ambulation restrictions and converting the approval from accelerated to traditional, and accelerated approval of Elevidys was primarily based on data from SRP-9001-102 and SRP-9001-103.
- 10 Oct 2023 Status changed from active, no longer recruiting to completed.