Table 6.

FDA and EMA approved biologic drugs for severe pediatric asthma.

Biologics	Mechanism of Action	Indications	Dosing Route
Benralizumab	Anti-IL5 (binds to IL5 receptor; causes apoptosis of eosinophils and basophils)	≥2 ys old Add-on maintenance treatment for adults and children with severe eosinophilic asthma (baseline blood eosinophil cell counts >300 cells/μL or >150 cells/μL for OCS-dependent patients) despite high-dosage ICS + LABA	30 mg s.c. every 4 wk for 3 doses; then every 8 wk
Dupilumab	Anti-IL4 (binds to IL4 receptor; blocks activation of IL4 and IL13 mediated inflammation)	≥12 ys old Add-on maintenance treatment for adults and adolescents with severe eosinophilic asthma (blood eosinophils > 150 cells/μL and/or raised FeNO >20 ppb) and chronic rhinosinusitis with nasal polyps which are uncontrolled despite medium-/high-dose ICS plus up to 2 additional controllers including OCS	200 or 300 mg s.c. every 2 wk
Mepolizumab	Anti-IL5 (binds to IL5 ligand; prevents IL5 from binding to receptor)	≥6 ys old Treatment for adults and children affected with severe asthma and peripheral eosinophilia (blood eosinophil level of either 300 cells or more per μL in the past 12 months or 150 cells or more per μL at initiation)	100 mg s.c. every 4 wk
Omalizumab	Anti-IgE (prevents IgE from binding to receptor)	≥6 ys old Treatment for adults and children with moderate-to-severe chronic allergic asthma, increase total IgE levels (total IgE level of 30–700 IU/mL considered in US; total IgE level of 30–1500 IU/mL considered in EU) and allergic sensitization to at least one perennial allergen	30–1500 IU/mL s.c. every 2–4 wk