WASHINGTON (dpa-AFX) - Alexion Pharmaceuticals, Inc. (ALXN) announced the company has submitted marketing applications to the U.S. FDA and the European Medicines Agency (EMA) to extend the indication for Soliris (eculizumab) as a treatment for patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. The company said both the U.S. and EU submissions are supported by the comprehensive data from the Phase 3 REGAIN study.
Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S., European Union, Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
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