21 August 2017 - First and only complement-based therapy approved for an ultra-rare subset of generelised myasthenis gravis.
Alexion Pharmaceuticals announced today that the European Commission approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalised 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 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 hospitalisation 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.