Drug updated on 6/5/2025
Dosage Form | Injection (subcutaneous; 100 mg single dose vial, 100 mg/mL single-dose prefilled autoinjector or single-dose; prefilled syringe, 40 mg/0.4 mL single-dose prefilled syringe) |
Drug Class | Interleukin-5 (IL-5) antagonist monoclonal antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype
- Indicated for add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP)
- Indicated for add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
- Indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
- Indicated for 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
Latest News

Summary
- This summary is based on the review of 31 systematic review(s)/meta-analysis(es). [1-31]
- In patients with asthma, mepolizumab reduced annualized asthma exacerbation rates by 56% for exacerbations requiring hospitalization or emergency department (ED) visits; in an Italian real-world cohort, clinically significant exacerbations decreased from 3.74 to 0.67 clinically significant exacerbations (CSEs)/patient/year.
- Dupilumab reduced asthma exacerbations more effectively than mepolizumab (relative risk (RR) 0.74 \[95% confidence interval (CI) 0.62 to 0.89]); benralizumab and reslizumab showed inconsistent efficacy in reducing annualized asthma exacerbation rate (AAER).
- In asthma populations, mepolizumab significantly improved Asthma Control Test (ACT) scores and showed variable forced expiratory volume in one second (FEV1) improvement, particularly in those with higher eosinophil counts; dupilumab generally produced greater lung function and quality of life improvements.
- For patients with chronic rhinosinusitis with nasal polyps (CRSwNP), mepolizumab significantly improved nasal polyp score and 22-item Sinonasal Outcome Test (SNOT-22) scores in real-world settings; dupilumab demonstrated superior efficacy, while omalizumab was less effective than dupilumab.
- Mepolizumab was generally well-tolerated with low discontinuation rates due to adverse events; commonly reported adverse events included headache and injection site reactions.
- Dupilumab showed a higher incidence of injection-site reactions compared to placebo and lower discontinuation rates due to adverse events compared to benralizumab.
- Benralizumab had a higher incidence of antidrug antibodies than other biologics and a higher risk of serious adverse events leading to discontinuation compared to placebo.
- Mepolizumab was particularly effective in patients with severe eosinophilic asthma, showed consistent benefits in real-world chronic rhinosinusitis with nasal polyps (CRSwNP) populations, and demonstrated limited efficacy in eosinophilic chronic obstructive pulmonary disease (COPD); in comparison, dupilumab and tezepelumab showed greater efficacy in patients with higher eosinophil counts for asthma, while dupilumab showed superior outcomes in CRSwNP and eosinophilic COPD subgroups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nucala (mepolizumab) Prescribing Information | 2025 | GlaxoSmithKline, Philadelphia, PA |