Alexion announces FDA approval of Soliris
Alexion Pharmaceuticals announced that the FDA has approved Soliris as a treatment for adult patients with generalized myasthenia gravis, or gMG, who are anti-acetylcholine receptor, or AchR, antibody-positive. In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing. These patients are at an increased risk of disease exacerbations and crises that may require hospitalization and intensive care and may be life-threatening. These patients represent approximately 5%-10% of all patients with MG.