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An Exploratory Study to Assess Two Doses of GSK2402968 in the Treatment of Ambulant Boys With Duchenne Muscular Dystrophy

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Trial Profile

An Exploratory Study to Assess Two Doses of GSK2402968 in the Treatment of Ambulant Boys With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Aug 2023

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At a glance

  • Drugs Drisapersen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms DEMAND V
  • Sponsors GlaxoSmithKline; GSK

Most Recent Events

  • 24 Nov 2015 According to a BioMarin Pharmaceutical media release, The Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. FDA has reviewed the NDA for drisapersen for the treatment of duchenne muscular dystrophy amenable to exon 51 skipping.
  • 20 Nov 2015 Results of pooled analysis of patients with comparable key baseline characteristics from this and two other clinical trials (700242338 and 700242352) published in a BioMarin Pharmaceutical media release.
  • 29 Jun 2015 According to a BioMarin Pharmaceutical media release, the US FDA accepted to review the submission of a New Drug Application (NDA) for Drisapersen for the treatment of DMD, amenable to exon 51 skipping, and has granted Priority Review status. The US FDA set the Prescription Drug User Fee Act goal date for a decision in December 2015.

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