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 controlled | EMA 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| Approval (COPD) | Phase 2 withdrawn Lack of eligible COPD subjects with elevated IgE | Phase 3 complete COPD with elevated eosinophil count | Phase 3 complete COPD with exacerbation history |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 urticaria | Eosinophilic 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.