FDA Approves GSK's First-in-Class Anti-IL-5 Biologic Nucala for Eosinophilic COPD

GSK announced today that the US FDA has approved its "first-in-class" antibody therapy Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and are not well controlled.According to the press release, Nucala is the first biologic to be studied in a diverse COPD population and approved for use in patients with the eosinophilic phenotype.`, the disease phenotype is characterized by a blood eosinophil count (BEC) ≥150 cells/μL.`

This FDA approval was based on the positive results of the Phase 3 clinical studies MATINEE and METREX. In these two studies,Nucala Demonstrates Clinically Meaningful and Statistically Significant Reduction in Annualized Rate of Moderate to Severe Exacerbations Compared to Placebo in COPD Patients with Diverse Eosinophilic Phenotypes.Preventing the exacerbation of acute conditions is a key objective in COPD management, as exacerbation events are highly detrimental to patients, leading to irreversible lung damage, worsening symptoms, and increased mortality risk. EosinophilsLevels are biomarkers of type 2 inflammation and can predict the risk of disease exacerbation in patients. Patients with a baseline BEC of ≥150 cells/μL are at higher risk of disease exacerbation.

In terms of safety, the incidence of adverse events was similar between the placebo group and the Nucala group.

COPD affects more than 300 million people globally, with up to 40% of patients exhibiting type 2 inflammation characteristics, namely elevated blood eosinophil counts. Interleukin-5 (IL-5) is a key cytokine in type 2 inflammation. Nucala was first approved in the United States in 2015 for the treatment of severe asthma with an eosinophilic phenotype.It is a monoclonal antibody targeting IL-5, developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.

References:

[1] Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). Retrieved May 22, 2025 from https://www.businesswire.com/news/home/20250522241746/en/Nucala-mepolizumab-approved-by-US-FDA-for-use-in-adults-with-chronic-obstructive-pulmonary-disease-COPD

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