The FDA approved mepolizumab (Nucala; GSK) today as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.1
Mepolizumab is a monoclonal antibody that targets IL-5, a cytokine with a central role in eosinophilic inflammation, which is present in 20% to 40% of patients with COPD. This approval makes it the first biologic with once-monthly dosing approved for this patient population and marks its fifth indication in the US.
Mepolizumab is also approved to treat patients aged 6 and older with severe eosinophilic asthma, adults with eosinophilic granulomatosis with polyangiitis, and those aged 12 and older with hypereosinophilic syndrome. In addition, it is approved as an add-on maintenance treatment for adults with chronic rhinosinusitis with nasal polyps.
FDA approves mepolizumab (Nucala; GSK) as the first monthly biologic for chronic obstructive pulmonary disease (COPD), significantly reducing exacerbations in patients with an eosinophilic phenotype. | Image Credit: Tada Images – stock.adobe.com
This most recent approval was supported by positive phase 3 MATINEE trial results (NCT04133909), published last week in the New England Journal of Medicine.2 In the trial, patients with COPD who were receiving triple inhaled therapy, had a history of exacerbations, and a blood eosinophil count of at least 300 cells per microliter were assigned 1:1 to receive either 100 mg of mepolizumab or a placebo subcutaneously every month for 52 to 104 weeks.
The primary end point was the annualized rate of moderate or severe COPD exacerbations. Secondary end points included the time to a patient’s first moderate or severe exacerbation, measures of health-related quality of life and symptoms, and the annualized rate of exacerbations resulting in an emergency department visit, hospitalization, or both.
A total of 403 patients were assigned to receive mepolizumab and 401 to placebo. The trial met its primary end point, with patients receiving mepolizumab showing a 21% reduction in annualized moderate or severe exacerbations compared with placebo (0.80 vs 1.01 events per year; rate ratio, 0.79; 95% CI, 0.66-0.94; P = .01). Additionally, the time to a patient’s first moderate or severe exacerbation was longer in the mepolizumab group (median time to first exacerbation, 419 vs 321 days; HR, 0.77; 95% CI, 0.64-0.93; P = .009).
Adverse event rates were similar between groups (mepolizumab vs placebo: 74% vs 77%), with the most frequent being the exacerbation or worsening of COPD (mepolizumab vs placebo: 12% vs 15%) and COVID-19 infection (12% in both groups). However, between-group differences in measures of health-related quality of life and symptoms were not significant.
Overall, the researchers concluded that adding mepolizumab to background triple inhaled therapy reduced the annualized rate of moderate or severe exacerbations in patients with COPD and an eosinophilic phenotype.
“Every physician will know the feeling of seeing a patient hospitalized due to an exacerbation that could have possibly been prevented,” Frank Sciurba, lead investigator of the MATINEE trial, said in a press release.3 “The MATINEE trial uncovers new possibilities in the treatment landscape for COPD patients with type 2 inflammation, as we strive to target drivers of disease and improve the lives of patients suffering with COPD.”
References
- Approval press release
- Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations of COPD with an eosinophilic phenotype. N Engl J Med. 2025;392(17):1710-1720. doi:10.1056/nejmoa2413181
- Nucala (mepolizumab) delivers clinically meaningful and statistically significant reduction in COPD exacerbations, with positive MATINEE trial results published in New England Journal of Medicine. News release. GSK; April 30, 2025. Accessed May 6, 2025. https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-delivers-clinically-meaningful-and-statistically-significant-reduction-in-copd-exacerbations-with-positive-matinee-trial-results-published-in-nejm/
