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: 09 Feb 2018

At a glance

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

    • 26 Dec 2017 According to an Alexion Pharmaceuticals media release, the Ministry of Health, Labour and Welfare (MHLW) of Japan in December 2017 approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).
    • 01 Dec 2017 Results published in the Lancet Neurology
    • 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.
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