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Drugs
Published in: Drugs 18/2015

01-12-2015 | AdisInsight Report

Mepolizumab: First Global Approval

Author: Gillian M. Keating

Published in: Drugs | Issue 18/2015

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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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Metadata
Title
Mepolizumab: First Global Approval
Author
Gillian M. Keating
Publication date
01-12-2015
Publisher
Springer International Publishing
Published in
Drugs / Issue 18/2015
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-015-0513-8

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