Alexion: Soliris study results show sustained treatment benefits
Alexion Pharmaceuticals announced results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris for the treatment of patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. The new results show sustained treatment benefits across a range of MG-specific assessment scales through an additional 52 weeks for patients who continued to receive Soliris, and also demonstrate rapid, significant and sustained improvements through 52 weeks for patients who had crossed over from placebo in REGAIN to Soliris treatment in the extension study. The safety profile of Soliris was consistent with that observed in the REGAIN study. "There is an urgent need for a treatment for patients with refractory gMG who have attempted multiple therapies and continue to suffer from severe symptoms and complications," said Professor James F. Howard, MD, Department of Neurology at the University of North Carolina, Chapel Hill, USA, and lead investigator in REGAIN and its open-label extension study. "These new results build on the findings of the REGAIN study, and it is encouraging to see the rapid and sustained benefits of Soliris treatment with patients recovering functional ability to carry out activities of daily living, and quality of life."