ISSUE 1486
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The FDA has approved mepolizumab (Nucala - GSK), a subcutaneously injected humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients ≥12 years old who have an eosinophilic phenotype.
EOSINOPHILIC PHENOTYPE — Severe asthma has been defined as asthma that can only be controlled with high-dose inhaled glucocorticoids plus a second controller medication and/or systemic glucocorticoids, or that remains uncontrolled despite this therapy. What constitutes an eosinophilic phenotype is not well defined, but patients in this category generally have severe disease with high eosinophil levels in blood and sputum despite treatment with a glucocorticoid.1
MECHANISM OF ACTION — IL-5 is the major cytokine responsible for the growth, differentiation, recruitment, and activation of
... more- KF Chung et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43:343.
- ID Pavord et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380:651.
- HG Ortega et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371:1198.
- 4. EH Bel et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371:1189.
- W Busse et al. High eosinophil count: a potential biomarker for assessing successful omalizumab treatment effects. J Allergy Clin Immunol 2013; 132:485.
- P Haldar et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133:921.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. January 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.
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