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Alexion (ALXN) Release: Interim Analysis From Phase III Open-Label Extension Study Shows Sustained Benefits Of Soliris (Eculizumab) Treatment For Patients With Refractory Generalized Myasthenia Gravis

9/14/2017 6:59:40 AM

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NEW HAVEN, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today results from an interim analysis of an ongoing Phase 3 open-label extension study of the pivotal, placebo-controlled REGAIN study of Soliris® (eculizumab) for the treatment of patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) 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. The results are presented at the annual meeting of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) in Phoenix, Arizona.

“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.”

Results presented show that the benefits for patients treated with Soliris in REGAIN through 26 weeks were maintained in the extension study across all four assessment scales for an additional 52 weeks (78 weeks in total). For patients who received placebo in REGAIN and then were treated with Soliris in the extension study, significant treatment benefits occurred within 1 to 4 weeks and were sustained through 52 weeks across all four assessment scales.1

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