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An open-label extension study of the long-term safety, tolerability and efficacy of drisapersen in subjects with Duchenne Muscular Dystrophy.

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Trial Profile

An open-label extension study of the long-term safety, tolerability and efficacy of drisapersen in subjects with Duchenne Muscular Dystrophy.

Status: Discontinued
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Drisapersen (Primary) ; Drisapersen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical

    • Most Recent Events

    • 05 Oct 2021 This trial has been completed in Spain, according to European Clinical Trials Database. (2016-09-09)
    • 05 May 2017 This trial has been completed in Germany (End date:2016-09-09) as per European Clinical Trials Database record.
    • 31 May 2016 According to a BioMarin media release, the company has withdrawn its MAA for drisapersen (Kyndrisa) from the EMA following discussions at the May 2016 CHMP meeting.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.
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