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Benralizumab: First Global Approval

Drugs volume 78, pages 505–511 (2018)Cite this article

Abstract

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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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    A. Markham

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  1. A. Markham
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Correspondence to A. Markham.

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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.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/1CFCF0606E51C358.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A. Benralizumab: First Global Approval. Drugs 78, 505–511 (2018). https://doi.org/10.1007/s40265-018-0876-8

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  • DOI: https://doi.org/10.1007/s40265-018-0876-8