U.S. License Holder:
Alexion Pharm.
Date of License:
December-21-2018
Last Update:
Sep-30-2024
FDA-Approved Indications
ULTOMIRIS (ravulizumab-cwvz) is a complement inhibitor indicated for:
The treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH);
The treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (™A);
The treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive;
The treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.