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An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Trial Profile

An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2019

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At a glance

  • Drugs Drisapersen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms DEMAND IV
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 31 May 2016 According to a BioMarin media release, the company has withdrawn its MAA for drisapersen (Kyndrisa) from the EMA following discussions at the May 2016 CHMP meeting. Those discussions clearly indicated that the CHMP intended to issue a negative opinion. BioMarin intends to discontinue clinical and regulatory development of Kyndrisa as well as the three other first-generation follow-on products, BMN 044, BMN 045 and BMN 053.
    • 21 Apr 2015 Results were presented at the 67th Annual Meeting of the American Academy of Neurology.
    • 28 Sep 2014 Status changed from active, no longer recruiting to discontinued as reported by ClinicalTrials.gov.
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