Benralizumab: First Global Approval

Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra (TM))-a humanised anti-interleukin-5 receptor alpha chain (IL-5R alpha) monoclonal antibody-as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype. This article summarizes the milestones in the development of benralizumab leading to this first approval for the treatment of severe eosinophilic asthma.