Alexion receives marketing authorization for Soliris in Japan
Alexion Pharmaceuticals announced that the Ministry of Health, Labour and Welfare in Japan has approved Soliris as a treatment for patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmapheresis. Soliris is the first and only complement inhibitor approved in Japan as a treatment for these patients. 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 hospitalization and intensive care and may be life-threatening. Japan's MHLW based its approval of this new indication of Soliris on comprehensive clinical data from the Phase 3, randomized, double-blind, placebo-controlled, multicenter REGAIN study. Soliris is also approved in the EU for the treatment of refractory gMG in adults who are anti-AChR antibody-positive, and in the U.S. for the treatment of adult patients with gMG who are anti-AchR antibody-positive.