FDA Approves Soliris® (Eculizumab) For The Treatment Of Patients With Generalized Myasthenia Gravis (GMG)

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (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.1-6

“Today’s approval is a significant milestone for Alexion and, more importantly, for the subset of patients with anti-AchR antibody-positive gMG who continue to suffer from significant unresolved disease symptoms despite existing treatment options,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “We are proud that we could apply our deep understanding of complement biology to develop Soliris for the treatment of patients with this debilitating neuromuscular disorder.”

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http://news.alexionpharma.com/press-release/product-news/fda-approves-so...

 

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