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A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

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Trial Profile

A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2023

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At a glance

  • Drugs Delandistrogene moxeparvovec (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARK
  • Sponsors Sarepta Therapeutics
  • Most Recent Events

    • 22 Dec 2023 According to a Sarepta Therapeutics media release, the company has submitted an efficacy supplement to the Biologics License Application (BLA) to US FDA with a request for Priority Review for ELEVIDYS (delandistrogene moxeparvovec-rokl) to expand its labeled indication as follows [ELEVIDYS is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene, supported by results from EMBARK and ENDEAVOR trial.
    • 30 Oct 2023 According to a Sarepta Therapeutics media release, the company has shared topline results with FDA leadership and they have confirmed that, based on the totality of the evidence, they are open to such label expansion if supported by review of the data, and that they intend to proceed rapidly with consideration of the submission.
    • 30 Oct 2023 Primary endpoint (Part 1: Change From Baseline in NSAA Total Score at Week 52) has not been met, according to a Sarepta Therapeutics media release.
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