The FDA has approved benralizumab (Fasenra – AstraZeneca), a humanized monoclonal antibody selective for the interleukin-5 (IL-5) receptor, for add-on maintenance treatment of severe asthma in patients ≥12 years old with an eosinophilic phenotype. Benralizumab is the third anti-IL-5 antibody to be approved for treatment of severe eosinophilic asthma; mepolizumab (Nucala) and reslizumab (Cinqair), which target IL-5 itself, were approved earlier.1,2

MECHANISM OF ACTION — Severe asthma often has an eosinophilic phenotype with elevated blood and lung eosinophil levels.3,4 IL-5 is the major cytokine responsible for the growth, differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab and reslizumab, the two previously approved anti-IL-5 antibodies, reduce the production and survival of eosinophils by binding to IL-5, preventing it from binding...  Continue reading

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Previous Issue: 1540      February 12, 2018
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The FDA has approved a subcutaneous (SC) extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Sublocade – Indivior) for once-monthly treatment of moderate to severe opioid use disorder.1 Sublocade is the first injectable buprenorphine product to be approved in the US. Buprenorphine is also available in sublingual formulations with or without the opioid antagonist naloxone, in a buccal formulation with naloxone, and as a subdermal implant ... Continue reading