Drug updated on 7/25/2024
Dosage Form | Injection (subcutaneous; 100 mg, 100 mg/mL, 40 mg/0.4 mL) |
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 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
- 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 ≥6 months without an identifiable non-hematologic secondary cause.
Latest News
Summary
- Mepolizumab (Nucala) is indicated for add-on maintenance treatment of severe asthma with an eosinophilic phenotype, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
- A total of 33 studies from systematic reviews and meta-analyses were reviewed.
- In pediatric CRSwNP, mepolizumab shows potential but requires additional phase III trials to confirm its efficacy compared to other biologics like dupilumab.
- Safety profile analysis indicates that mepolizumab has a comparable adverse event profile to placebo, though it reports unique observations such as upper respiratory tract infections and pulmonary mass issues.
- For type 2 high asthma patients, mepolizumab demonstrates lesser improvement in lung function compared to tezepelumab and dupilumab which show superior outcomes in exacerbations reduction.
- In treating EGPA, both 100 mg and 300 mg doses of mepolizumab are effective. It presents notable relapse rates but remains well-studied through randomized controlled trials compared to benralizumab's preliminary results.
- Real-world studies reinforce the efficacy seen in controlled trials for severe asthma by showing significant reductions in exacerbation rates, mean daily oral corticosteroid dose requirements, improved lung function, and health-related quality of life improvements when using mepolizumab.
- Comparative analyses indicate that while dupilumab often outperforms or matches the effectiveness of mepolizumab across various indications including CRSwNP management; however, further direct head-to-head comparisons are required.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nucala (mepolizumab) Prescribing Information. | 2023 | GlaxoSmithKline LLC., Philadelphia, PA |