U.S. License Holder:
GlaxoSmithKline LLC
Date of License:
November-04-2015
Last Update:
January-08-2021
FDA-Approved Indications
NUCALA (mepolizumab) is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:
Add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype;
The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA);
The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.