Key Takeaways
- Nucala Becomes First Biologic Approved for COPD with Eosinophilic Inflammation
The FDA’s approval of GSK’s Nucala (mepolizumab) introduces the first biologic treatment for patients with chronic obstructive pulmonary disease(COPD) with blood eosinophil counts as low as ≥150 cells/μL, expanding treatment options for a previously underserved population. - Clinical Trials Show Reduced Exacerbations and Extended Time to Relapse
Data from the Phase III MATINEE and METREX trials showed that Nucala significantly reduced the rate of moderate and severe COPD exacerbations, and increased the median time to first exacerbation, offering patients improved disease control. - New Hope for COPD Patients Struggling with Standard Inhaled Therapies
Nucala provides a promising new option for COPD patients who remain inadequately managed on inhaled maintenance therapies, especially those with an eosinophilic phenotype—a population often prone to frequent flare-ups and hospitalizations.
The FDA has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and are inadequately controlled on current therapies. This marks the first biologic approved for COPD patients with blood eosinophil counts (BEC) as low as ≥150 cells/μL.
The approval is based on results from the Phase III METREX and MATINEE trials, which demonstrated statistically significant and clinically meaningful reductions in moderate and severe exacerbations compared to placebo.1
What Does This Mean for COPD Patients with Limited Treatment Options?
“The approval of Nucala in the US provides an important option for COPD patients,” said Kaivan Khavandi, SVP, global head, respiratory, immunology, inflammation, GSK, in a press release. “Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions. Today there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150cells/μL who need new options like Nucala to support their treatment journey.”
Clinical Trial Design and Treatment Approach
The randomized, double-blind, parallel-group MATINEE and METREX trials assessed the efficacy and safety of Nucala administered subcutaneously every four weeks versus placebo in addition to optimal inhaled triple therapy.
MATINEE Study: Efficacy in Patients with Type 2 Inflammation
MATINEE assessed 804 patients over 52 to 104 weeks in COPD patients with evidence of type 2 inflammation, characterized by a blood eosinophil count (≥300 cells/µL). The conditions of participants ranged from moderate to severe, or stages 2–4 as assessed by the medically recognized scale of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
During the trial, 403 patients were randomly assigned to the treatment arm and 401 to the placebo arm.1 The primary endpoint of the study was the annualized rate of moderate or severe exacerbations. Key secondary endpoints included time to first moderate or severe exacerbation, measures of health-related quality of life and symptoms, and the annualized rate of exacerbations leading to an emergency department visit or hospitalization.
Results showed that Nucala significantly reduced the annualized rate of moderate or severe COPD exacerbations compared to placebo (0.80 vs. 1.01 events per year; rate ratio 0.79; 95% CI, 0.66–0.94; P=0.01). Additionally, patients in the treatment arm experienced a median time of 419 days to their first exacerbation compared to 321 days in the placebo group. The safety profile and rates of adverse events (AEs) were comparable between both groups.2
METREX Study: Evaluating Eosinophilic and Non-Eosinophilic Phenotypes
METREX assessed the efficacy and safety of Nucala for 52 weeks in 836 patients who received either Nucala or placebo across two groups: the eosinophilic phenotype group (blood eosinophil count of ≥150 cells/µL at study entry or ≥300 cells/µL within the past year) and the non-eosinophilic phenotype group (blood eosinophil count of <150 cells/µL at study entry and no evidence of ≥300 cells/µL within the past year).1 The primary endpoint of the study was the annual rate of moderate or severe exacerbations.
Results found that Nucala reduced the mean annual rate of moderate or severe exacerbations to 1.40 compared to 1.71 in the placebo group. However, no significant difference was observed in the overall modified intention-to-treat population. Results found that Nucala reduced the mean annual rate of moderate or severe exacerbations to 1.40 compared to 1.71 in the placebo group. However, no significant difference was observed in the overall modified intention-to-treat population.3
Biologics Bring Renewed Hope to COPD Community
“COPD isn’t just a disease; it’s a relentless cycle,” said Jean Wright, MD, MBA, CEO, the COPD Foundation, in the press release. “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.”
References
Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). GSK. May 22, 2025. Accessed May 23, 2025. https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/
Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. The New England Journal of Medicine. April 30, 2025. Accessed May 23, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2413181
Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. The New England Journal of Medicine. October 26, 2017. Accessed May 23, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa1708208
