European Commission approves Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG).- Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals, Inc. announced that the European Commission (EC) 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. Soliris is the first and only complement-based therapy approved in the European Union (EU) for this ultra-rare subset of patients.

Patients with refractory gMG can have difficulties walking, talking, swallowing and breathing normally despite therapies currently used for MG. Exacerbations and crises of their disease may require hospitalization and intensive care and may be life-threatening.

Soliris will be launched for this new indication initially in Germany, and Alexion is evaluating launches in additional EU countries. Chronic uncontrolled activation of the complement cascade, a part of the immune system, can play a major role in the debilitating symptoms and potentially life-threatening complications of refractory gMG. Soliris is a first-in-class complement inhibitor that specifically and effectively inhibits the terminal part of the complement cascade.