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Mepolizumab: First Global Approval

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Abstract

Mepolizumab (Nucala®) is a fully humanized monoclonal antibody against interleukin-5 (IL-5) that is being developed by GlaxoSmithKline. Subcutaneous mepolizumab is approved in the USA for the add-on maintenance treatment of patients aged ≥12 years with severe asthma and an eosinophilic phenotype, and is awaiting approval in the EU. Mepolizumab blocks IL-5 and reduces blood and sputum eosinophil counts in patients with asthma. In the phase III MENSA trial in patients with recurrent asthma exacerbations and evidence of eosinophilic inflammation despite high-dose inhaled glucocorticoid therapy, mepolizumab significantly reduced the annualized exacerbation rate. In the phase III SIRIUS trial, mepolizumab had an oral glucocorticoid-sparing effect in patients with severe eosinophilic asthma requiring systemic glucocorticoid maintenance therapy. This article summarizes the milestones in the development of mepolizumab leading to this first approval for severe asthma with an eosinophilic phenotype.

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

    Gillian M. Keating

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  1. Gillian M. Keating
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Correspondence to Gillian M. Keating.

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The preparation of this review was not supported by any external funding. 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 author on the basis of scientific completeness and accuracy. Gillian Keating is a salaried employee of Adis, Springer SBM.

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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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Keating, G.M. Mepolizumab: First Global Approval. Drugs 75, 2163–2169 (2015). https://doi.org/10.1007/s40265-015-0513-8

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