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# FDA Approves sBLA for Soliris Expanded Use
- URL: https://www.fdaweb.com/fda-approves-sbla-for-soliris-expanded-use/
- Published: 2017-10-25T12:00:00.000Z
- Updated: 2026-09-14T22:58:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139958

FDA has approved an Alexion Pharmaceuticals supplemental BLA for Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris is described as a first-in-class terminal complement inhibitor, and is approved in the U.S. for treating patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis. Approval for the expanded indication is based on data from the Phase 3 REGAIN study that “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,” the company says.