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)
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
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History