FDA Approves Nucala for Chronic Obstructive Pulmonary Disease

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The U.S. Food and Drug Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD).

Nucala stands out as the only approved biologic that has been specifically evaluated in patients whose eosinophilic phenotype is defined by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL. As many as 70 percent of COPD patients in the United States whose disease is not adequately controlled with inhaled triple therapy and who continue to experience exacerbations have a BEC ≥150 cells/µL.

Approval of Nucala was based on the results of two phase 3, randomized (1:1), double-blind, parallel-group trials, MATINEE and METREX, both of which examined Nucala 100 mg administered subcutaneously every four weeks in addition to optimal inhaled triple therapy.

In the MATINEE trial, which was presented at the American Thoracic Society 2025 International Congress, 804 patients with COPD with a BEC of ≥300 cells/µL saw a statistically significant reduction in moderate or severe exacerbations when Nucala (versus placebo) was added to triple inhaled therapy (0.80 versus 1.01 events per year; rate ratio, 0.79). In a predefined secondary end point, the rate of COPD exacerbations requiring emergency department visits or hospitalization decreased (rate ratio, 0.65).

In the METREX trial, results were similar, with patients taking Nucala (versus placebo) seeing a significant decrease in moderate or severe exacerbations (1.40 versus 1.71 events per year; rate ratio, 0.82). 

Adverse events reported were similar for the Nucala and placebo groups.

“COPD isn’t just a disease, it’s a relentless cycle,” Jean Wright, M.D., chief executive officer of the COPD Foundation, said in a statement. “For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”

Approval of Nucala was granted to GSK.

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Source: HealthDay

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