FDA OKs First Biologic to Treat COPD with Eosinophilic Phenotype: Daily Dose

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On May 23, 2025, we reported on the US FDA approval of mepolizumab (Nucala; GSK) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

The approval

The approval makes the monoclonal antibody, which targets and binds to interleukin (IL)-5, the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL.

The FDA based its decision on data from the MATINEE2 and METREX phase 3 trials, which demonstrated that mepolizumab significantly reduced the annualized rate of moderate/severe exacerbations (AER) vs placebo in adults with COPD and evidence of type 2 inflammation, ie, BEC of 300 or more cells/μL.

In MATINEE, mepolizumab reduced the rate of moderate to severe exacerbations by 21% vs placebo. METREX data revealed similar benefits, with mepolizumab-treated participants experiencing reduction in exacerbations of 18%. A predefined secondary endpoint in MATINEE showed mepolizumab reduced the annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization compared with placebo by 35%, though this was not statistically significant due to failure of an endpoint higher in the predefined statistical testing hierarchy.

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