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A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

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Trial Profile

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Omaveloxolone (Primary)
  • Indications Friedreich's ataxia
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms MOXIe
  • Sponsors Biogen; Reata Pharmaceuticals

    • Most Recent Events

    • 12 Feb 2024 According to a Biogen media release, company announced the European Commission (EC) has authorized SKYCLARYS (omaveloxolone) for the treatment of Friedreich's ataxia (FA) in adults and adolescents aged 16 years and older based on the efficacy and safety data from MOXIe Part 2 trial.
    • 15 Dec 2023 According to a Biogen media release, the European Commission (EC) will review SKYCLARYS (omaveloxolone) for marketing authorization in the European Union and final decision expected in the first quarter of 2024.
    • 15 Dec 2023 According to a Biogen media release, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS (omaveloxolone) for the treatment of Friedreich ataxia (FA) in people aged 16 years and older.
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