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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

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

Latest Information Update: 08 Nov 2019

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At a glance

  • Drugs Satralizumab (Primary)
  • Indications Neuromyelitis optica
  • Focus Registrational; Therapeutic Use
  • Acronyms SAkuraStar
  • Sponsors Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 30 Oct 2019 According to a Chugai Pharmaceutical media release, European Medicines Agency (EMA) accepted the Marketing Authorisation Application and the US FDA accepted the Biologics License Application (BLA) for satralizumab in adult and adolescent patients with neuromyelitis optica spectrum disorder. EMA granting it Accelerated Assessment. The CHMP recommendation and the FDA decision are expected in 2020. The applications are based on the phase III trial SakuraStar study and SAkuraSky study.
    • 24 Oct 2019 Planned End Date changed from 31 Mar 2021 to 20 Aug 2021.
    • 13 Sep 2019 According to a Chugai Pharmaceutical media release, based on the data from SakuraStar Study and SAkuraSky Study, the Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation for Satralizumab in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder.
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