ECU-MG-302, A Phase III, Open-label, Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Trial Profile

ECU-MG-302, A Phase III, Open-label, Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Eculizumab (Primary)
  • Indications Myasthenia gravis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 21 Aug 2017 According to an Alexion Pharmaceuticals media release, European Commission (EC) has approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
    • 23 Jun 2017 According to an Alexion Pharmaceuticals media release, company received positive CHMP opinion for Soliris (Eculizumab) for the treatment of patients with refractory generalized Myasthenia Gravis (gMG) in the European Union.
    • 17 Jul 2016 Status changed from recruiting to active, no longer recruiting.
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