A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001

Trial Profile

A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001

Completed
Phase of Trial: Phase II

Latest Information Update: 21 Jun 2016

At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions
  • Acronyms DELPHI Extension
  • Sponsors Santhera Pharmaceuticals
  • Most Recent Events

    • 21 Jun 2016 According to Santhera media release, a Marketing Authorization Application (MAA) for idebenone (Raxone) for the treatment of Duchenne muscular dystrophy (DMD) in patients with respiratory function decline who are not taking concomitant glucocorticoids has been validated by the European Medicines Agency (EMA).
    • 31 May 2016 According to Santhera media release, feedback from the FDA related to NDA filing is currently expected by the end of July.
    • 31 May 2016 According to Santhera media release, a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was submitted for Raxone (idebenone) for the treatment of Duchenne muscular dystrophy (DMD) as Type II variation of the company's existing marketing authorization for Raxone granted last year and this regulatory dossier summarizes data from DELPHI program and DELOS study.
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