FDA Approves Nucala (Mepolizumab) for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

The U.S. Food and Drug Administration (FDA) has officially approved GSK's medication Nucala (mepolizumab) as an add-on therapy for adults suffering from moderate to severe chronic obstructive pulmonary disease (COPD) that remains inadequately controlled with standard treatments. This approval marks a significant development in COPD management, especially for patients with an eosinophilic phenotype characterized by a blood eosinophil count (BEC) of at least 150 cells/µL. It is noteworthy that up to 70% of patients in the United States, who experience ongoing exacerbations despite adhering to inhaled triple therapy, have a BEC at or above this threshold.

The safety and efficacy of Nucala were established through two rigorous Phase III clinical trials, MATINEE and METREX. Both studies involved administering 100 mg of Nucala via subcutaneous injection every four weeks, alongside optimized inhaled triple therapy. In the MATINEE trial, which involved 804 COPD patients with BEC levels of 300 cells/µL or higher, results showed a noteworthy reduction in exacerbations requiring medical intervention. Specifically, the frequency of moderate or severe exacerbations decreased from 1.01 events per year with placebo to 0.80 with Nucala, corresponding to a rate ratio of 0.79. Additionally, severe exacerbations necessitating emergency visits or hospitalization were reduced by 35%. Similarly, the METREX trial revealed a significant reduction in exacerbation rates, with patients receiving Nucala experiencing 1.40 events per year compared to 1.71 in the placebo group, a rate ratio of 0.82.

Adverse effects reported in both studies were comparable between the Nucala and placebo groups, supporting the drug's safety profile. COPD is a progressive disease that involves persistent respiratory symptoms and episodic exacerbations, often leading to impaired quality of life. Jean Wright, M.D., CEO of the COPD Foundation, highlighted the importance of this advancement, stating that biologics like mepolizumab offer new hope for individuals managing this challenging condition.

This approval provides healthcare professionals with a novel targeted therapy option that addresses the eosinophilic component of COPD, potentially reducing the frequency and severity of exacerbations, and improving patient outcomes.

For more information: GSK Press Release

Source: https://medicalxpress.com/news/2025-05-fda-nucala-chronic-obstructive-pulmonary.html