Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)—a humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) 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.
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The preparation of this review was not supported by any external funding.
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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Markham, A. Benralizumab: First Global Approval. Drugs 78, 505–511 (2018). https://doi.org/10.1007/s40265-018-0876-8