A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2017

At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGAIN
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 23 Oct 2017 According to an Alexion Pharmaceuticals media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive.
    • 13 Sep 2017 According to an Alexion Pharmaceuticals media release, James F. Howard is a lead investigator of the study.
    • 21 Aug 2017 According to an Alexion media release supplemental new drug application in Japan for Soliris as a treatment for patients with anti-AChR antibody-positive refractory gMG have been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW).
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