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Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2

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Trial Profile

Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Edaravone (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 19
  • Sponsors Mitsubishi Tanabe Pharma America; Mitsubishi Tanabe Pharma Corporation
  • Most Recent Events

    • 08 Apr 2024 According to a Mitsubishi Tanabe Pharma America media release, company announced the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis. The U.S. approval of RADICAVA (edaravone) was based on this pivotal Phase 3 study (Study 19 or MCI186-19).
    • 01 Oct 2023 Results of post hoc analysis accessing The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis published in the Muscle and Nerve.
    • 17 Aug 2023 According to a Mitsubishi Tanabe Pharma Corporation media release, post-hoc analysis was funded and conducted by MTPA.
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