New indication for Soliris approved in Europe

The European Commission today approved the extension of the indication for USA-based Alexion Pharmaceuticals’ (Nasdaq: ALXN) 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 for this ultra-rare subset of patients. Soliris will be launched for this new indication initially in Germany, and Alexion is evaluating launches in additional European Union countries.

“Patients with refractory gMG have exhausted multiple therapies and continue to suffer from severe symptoms and complications that markedly impact their daily lives,” said Dr Renato Mantegazza, from the Department of Neuroimmunology and Neuromuscular Diseases, at the Istituto Neurologico Carlo Besta in Milan, Italy, and an investigator in the Phase III REGAIN study. “There is an urgent need for therapy for these patients, and it’s exciting to have a product such as Soliris available that has demonstrated in clinical studies that it improves patients’ symptoms and their ability to undertake daily activities.”