Drug updated on 4/29/2024
| Dosage Form | Injection (subcutaneous; 30 mg/mL) |
| Drug Class | Interleukin-5 receptor alpha-directed cytolytic monoclonal antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Summary
- Benralizumab (Fasenra) is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, specifically those with an eosinophilic phenotype.
- A total of 10 systematic reviews/meta-analyses were reviewed to gather information about Fasenra's efficacy and safety in treating severe asthma.
- In a comparison study involving tezepelumab, dupilumab, benralizumab, and mepolizumab for the treatment of eosinophilic asthma, it was found that tezepelumab had significantly lower exacerbation rates than benralizumab but similar improvements in FEV1.
- Another network meta-analysis comparing five treatments, including tezepelumab, dupilumab, benralizumab, mepolizumab, and a placebo, showed that there was a significant difference in efficacy between tezepelumab and the other treatments across all participants, as well as patient subgroups based on peripheral blood eosinophil count (PBEC).
- An indirect comparison between licensed dosage administrations of dupilumab and benralizumab for inadequately controlled asthma showed no significant difference in the annual exacerbation rate (AER). However, dupilumab was superior to benralizumab in patients with higher blood eosinophil counts.
- Despite its effectiveness at reducing exacerbations compared to placebo by up to 52%, some studies have raised concerns over adverse events associated with Fasenra use such as headache and pyrexia; more data on long-term safety are needed together with more efficacy data in pediatric population according to one review article.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Fasenra (benralizumab) Prescribing Information. | 2021 | AstraZeneca Pharmaceuticals LP., Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Benralizumab (Fasenra®) protocol for the treatment of Severe refractory eosinophilic asthma. | 2023 | National Clinical Programme for Respiratory Medicine |
| Severe asthma: adding new evidence –Latin American Thoracic Society. | 2021 | ERJ Open Research |
| EAACI biologicals guidelines—recommendations for severe asthma. | 2021 | Allergy |
| Global strategy for asthma management and prevention. | 2020 | GINA |