Drug updated on 5/3/2024
| 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.
Summary
- Mepolizumab (Nucala) is indicated for add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and an eosinophilic phenotype, chronic rhinosinusitis with nasal polyps in adults, eosinophilic granulomatosis with polyangiitis in adults, as well as hypereosinophilic syndrome in adult and pediatric patients aged 12 years or older.
- A total of 25 systematic reviews/meta-analyses were reviewed to gather information about the safety, efficacy, population considerations of mepolizumab (Nucala).
- Compared to Benralizumab, mepolizumab shows a lower incidence of treatment-emergent antidrug antibodies indicating potentially lower risk of immunogenicity.
- In terms of effectiveness against Dupilumab for treating severe asthma with an eosinophilic phenotype both drugs show substantial benefits but Dupilimub may have broader applications due to its efficacy across wider range of eosinophils counts.
- When compared to Omalizumab which targets different pathways in asthma management; Mepoluzimba's role might be more focused on controlling eosoniphillic inflammation rather than broad spectrum asthma management where Omaluzimba has shown benefit.
- Against Reslizuamb and Tezpelumb; Mepoluzaib offers comparable safety profile while maintaining competitive edge over other biologics by reducing exacerbation rates especially among those suffering from severe eosophillc asthama based on eosophill count reduction data available so far.
- Across all studies reviewed it was found that mepoluzaib exhibits favorable safety profile having relatively low incidences serious adverse events when compared other biologics used for similar indications.
- Most importantly evidence suggests that this drug is effective not only among adult patients but also among pediatric patients aged 6 years and older with severe asthma and an eosinophilic phenotype, demonstrating both efficacy in exacerbation rate reduction and safety.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nucala (mepolizumab) Prescribing Information. | 2023 | GlaxoSmithKline LLC., Philadelphia, PA |