Approval is for adult patients with COPD with eosinophilic inflammation<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
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FRIDAY, May 23, 2025 (HealthDay News) — 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).<\/p>\n
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 \u2265150 cells\/\u00b5L. 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 \u2265150 cells\/\u00b5L.<\/p>\n
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.<\/p>\n
In the MATINEE<\/a> trial, which was presented at the American Thoracic Society 2025 International Congress, 804 patients with COPD with a BEC of \u2265300 cells\/\u00b5L 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).<\/p>\n In the METREX<\/a> 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). <\/p>\n Adverse events reported were similar for the Nucala and placebo groups.<\/p>\n “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.”<\/p>\n Approval of Nucala was granted to GSK.<\/p>\n