Alexion Pharmaceuticals, Inc. announced that the company has submitted marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to extend the indication for Soliris® (eculizumab) as a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The European submission has been validated by the European Medicines Agency (EMA), marking the beginning of the review process in Europe for this potential new indication for Soliris. Both the U.S. and EU submissions are supported by the comprehensive data from the Phase 3 REGAIN study.