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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial for Duchenne Muscular Dystrophy Using SRP-9001

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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: 31 Oct 2024

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At a glance

  • Drugs Delandistrogene moxeparvovec (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Sponsors Sarepta Therapeutics

Most Recent Events

  • 20 Jun 2024 According to a Sarepta Therapeutics media release, company announced U.S. Food and Drug Administration (FDA) approval of an expansion to the labeled indication for ELEVIDYS to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. The FDA granted traditional approval for ambulatory patients and the FDA granted accelerated approval for non-ambulatory patients.
  • 20 Jun 2024 According to a Sarepta Therapeutics media release, company will host an investor conference call on June 21, 2024, at 8:30 a.m. ET to discuss this update.
  • 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.

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