U.S. License Holder:
Alexion Pharm.
Date of License:
March-16-2007
Last Update:
December-08-2019
FDA-Approved Indications
SOLIRIS (eculizumab) is a complement inhibitor indicated for:
The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis;
The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy;
The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive;
The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.