TABLE 4

Approved biological therapies for type 2 inflammatory airway diseases

Omalizumab
(anti-IgE)
Mepolizumab
(anti-IL-5)
Reslizumab
(anti-IL-5)
Benralizumab
(anti-IL-5R)
Dupilumab
(anti-IL-4R)
Tezepelumab
(anti-TSLP)
Approval (asthma)US indication:
patients with moderate-to-severe persistent allergic asthma aged ≥6 years
EMA indication:
patients with severe persistent allergic asthma aged ≥6 years
US indication:
patients with severe eosinophilic asthma aged ≥6 years
EMA indication:
patients with severe refractory eosinophilic asthma aged ≥6 years
US indication: patients with severe eosinophilic asthma aged ≥18 years
EMA indication: patients with severe refractory eosinophilic asthma aged ≥18 years
US indication: patients with severe eosinophilic asthma aged ≥12 years
EMA indication: patients with severe refractory eosinophilic asthma aged ≥18 years
US indication: patients with moderate-to-severe eosinophilic asthma or OCS-dependent asthma aged ≥6 years [142]
EMA indication: patients with severe asthma with type 2 inflammation (elevated FeNO/eosinophils) aged ≥12 years
US indication:
patients with severe asthma aged ≥12 years
Approval (CRSwNP)Approved EU and US CRSwNP inadequately controlledEMA indication: inadequately controlled severe CRSwNP
US indication: inadequately controlled CRSwNP [143]
Phase 3 recruiting
CRS with elevated eosinophils
Phase 3 complete
severe symptomatic bilateral nasal polyps
Approved EU and US
CRSwNP inadequately controlled
Phase 3 recruiting
Approval (COPD)Phase 2 withdrawn
Lack of eligible COPD subjects with elevated IgE
Phase 3 complete
COPD with elevated eosinophil count
Phase 3 complete
COPD with exacerbation history
Phase 3 recruiting
Moderate-to-severe COPD with type 2 inflammation
Phase 2a recruiting [144]
Approval (other)Chronic idiopathic urticariaEosinophilic granulomatosis with polyangiitis
Hypereosinophilic syndrome
Atopic dermatitis

IL: interleukin; TSLP: thymic stromal lymphopoietin; CRSwNP: chronic rhinosinusitis with nasal polyps; US: United States; EMA: European Medicines Agency; OCS: oral corticosteroids; FeNO: exhaled nitric oxide fraction; EU: European Union; CRS: chronic rhinosinusitis.