FDA to review mepolizumab for COPD with eosinophilic phenotype

The FDA has accepted to review a supplemental new drug application for mepolizumab, an anti-IL-5 biologic, for treating patients with COPD plus an eosinophilic phenotype, according to a GSK press release.

Notably, mepolizumab (Nucala, GSK) would be an add-on maintenance treatment in this patient population with this indication.

The release states that the FDA assigned a Prescription Drug User Fee Act target date of May 7, 2025.

According to the release, GSK’s submission to the FDA includes data from the MATINEE trial of 804 patients with COPD and type 2 inflammation who received either mepolizumab or placebo — both along with inhaled maintenance therapy — for 52 to 104 weeks. The results demonstrated “a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations” in the mepolizumab group.

As Healio previously reported, 100 mg mepolizumab every 4 weeks along with inhaled corticosteroid-containing triple therapy lowered annualized exacerbation rates among adults with COPD and heightened eosinophil levels in a post-hoc analysis of the METREX and METREO trials.

The MATINEE trial expands on these two trials and their findings, the release states.

Clinicans can expect to see full MATINEE study data at a future scientific congress, according to the release.