FDA Grants Approval for Nucala to Treat Chronic Obstructive Pulmonary Disease

The U.S. Food and Drug Administration (FDA) has officially approved Nucala (mepolizumab), developed by GlaxoSmithKline, as a complementary maintenance therapy for adult patients suffering from chronic obstructive pulmonary disease (COPD) who are not adequately managed with existing treatments.

Nucala is distinguished as the only biologic medication that has undergone extensive evaluation specifically for patients classified with an eosinophilic phenotype, characterized by a blood eosinophil count (BEC) threshold of >=150 cells/µL. Research indicates that approximately 70% of U.S. COPD patients who do not achieve sufficient control with inhaled triple therapy and continue to experience exacerbations exhibit a BEC of >=150 cells/µL.

The approval of Nucala was supported by findings from two Phase III clinical trials, MATINEE and METREX, which were designed as randomized, double-blind, parallel-group studies. Both trials investigated the efficacy of Nucala, administered at a dosage of 100 mg subcutaneously every four weeks, in conjunction with optimal inhaled triple therapy.

In the MATINEE trial, presented at the American Thoracic Society 2025 International Congress, 804 patients with COPD and a BEC of >=300 cells/µL experienced a statistically significant reduction in the frequency of moderate to severe exacerbations when Nucala was added to their existing treatment regimen, with an incidence rate of 0.80 compared to 1.01 events per year for the placebo group (rate ratio, 0.79). Additionally, there was a notable decrease in the rate of exacerbations that necessitated emergency department visits or hospitalization (rate ratio, 0.65).

The METREX trial yielded comparable results, demonstrating that patients receiving Nucala experienced a significant reduction in moderate to severe exacerbations, with a frequency of 1.40 events per year versus 1.71 events per year in the placebo group (rate ratio, 0.82). The adverse events reported were found to be similar between both the Nucala and placebo cohorts, indicating a favorable safety profile.

Experts in the field, including the chief executive officer of the COPD Foundation, have expressed optimism regarding the impact of biologic treatments like mepolizumab on the management of COPD. The relentless nature of COPD exacerbations poses ongoing challenges for patients, even those adhering to inhaled maintenance therapies. The introduction of Nucala presents a renewed opportunity for improved management of this chronic condition.