Summary of Clinical Use

In November 2017, the US FDA approved benralizumab as an add-on maintenance treatment for patients with severe eosinophilic phenotype asthma (aged 12 years and older). EMA marketing approval is pending a final decision, with their Committee for Medicinal Products for Human Use (CHMP) having recommended marketing authorisation on 9th November 2017 [3]. Results from Phase 3 clinical trial NCT01914757 are published in [4]. Analysis of trial outcomes show that not all asthma patients will respond to benralizumab, but that in patients with high eosinophil counts (> 300 cells per μL) annual exacerbation rates were significantly reduced. These suggest that targeting the biologic to specific patient populations will provide most clinical benefit. Click here to view ClinicalTrials.gov's listing of current benralizumab trials. FDA approval was expaned in September 2024 to include treatment of eosinophilic granulomatosis with polyangiitis (a rare immune-mediated vasculitis that causes sometimes fatal multiple organ damage).

Mechanism Of Action and Pharmacodynamic Effects

This antibody targets the interleukin 5 receptor alpha subunit (IL5RA; IL-5Rα) [5]. Antibody targeting of IL-5Rα depletes eosinophils in lung tissue and bone marrow, thereby reducing eosinophilic inflammation caused by allergen exposure [1,7].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT04157348	Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.	Phase 3 Interventional	AstraZeneca	In this study (MANDARA) benralizumab was found to be noninferior to mepolizumab for the induction of remission in patients with relapsing/refractory eosinophilic granulomatosis with polyangiitis (EGPA).	8