Alexion Pharma Announces Marketing Authorization For Soliris In Japan

(RTTNews) - Alexion Pharmaceuticals, Inc. (ALXN) announced the Ministry of Health, Labour and Welfare in Japan has approved Soliris (eculizumab) 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. The company said Japan's MHLW based its approval of the new indication of Soliris on 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 generalized myasthenia gravis in adults who are anti-AChR antibody-positive, and in the U.S. for the treatment of adult patients with generalized myasthenia gravis who are anti-AchR antibody-positive.