23 October 2017 - First FDA approved treatment in more than 60 years for patients with generalised myasthenia gravis, a chronic and debilitating neuromuscular disorder

Alexion Pharmaceuticals announced today that the U.S. FDA has approved Soliris (eculizumab) as a treatment for adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. 

In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing. These patients are at an increased risk of disease exacerbations and crises that may require hospitalisation and intensive care and may be life-threatening. These patients represent approximately 5-10% of all patients with MG.

Read Alexion Pharmaceuticals press release