FDA

Nucala OK’d for COPD with eosinophilic phenotype

May 26, 2025

FDA approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

Efficacy

Approval was based on data from the phase 3 MATINEE (NCT04133909) and METREX (NCT02105948) trials. In both trials, mepolizumab demonstrated a statistically significant reduction in the annualized rate of moderate or severe exacerbations compared with placebo, in patients with an eosinophilic phenotype, when added to triple inhaled therapy (MATINEE: rate ratio [RR], 0.79; 95% confidence interval [CI], 0.66-0.94; P=0.01) (METREX: RR, 0.82; 95% CI, 0.68-0.98; adjusted P=0.04). In a pre-defined secondary endpoint in MATINEE, the annualized rate of COPD exacerbations requiring ED visits and/or hospitalization was reduced in the mepolizumab group vs. placebo (RR, 0.65; 95% CI, 0.43-0.96 [not statistically significant due to a failure of an endpoint higher in the pre-defined statistical testing hierarchy]).

Safety

The most common adverse reactions reported in COPD trials were back pain, diarrhea, and cough.

Recommended dose

The recommended dosage of Nucala for COPD is 100mg SC q4wks.

Sources:

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). [News release]. 2025. https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/

Nucala (mepolizumab) [package insert]. GSK. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF Revised May 2025. Accessed May 22, 2025.