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A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

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Trial Profile

A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

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

    • Most Recent Events

    • 11 Mar 2022 According to a PTC Therapeutics media release, results evaluating associations between Deflazacort vs Prednisone/prednisolone and disease progression markers in subgroup of patients with Duchenne Muscular Dystrophy (NCT01826487, NCT01865084, NCT00592553, NCT01254019) will be presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference 2022. Abstract is available on the MDA Conference website.
    • 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 According to a BioMarin Pharmaceutical media release, the Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the Kyndrisa NDA is December 27, 2015.

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