The U.S. Food and Drug Administration (FDA) has granted approval to GSK plc’s Nucala (mepolizumab) as an add-on maintenance treatment for adult patients suffering from inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This decision marks a significant advancement in the management of a challenging subset of COPD, offering a targeted biologic therapy to patients at high risk of exacerbations.

The FDA’s approval is underpinned by robust data from the positive MATINEE and METREX Phase III clinical trials. These trials demonstrated that mepolizumab yielded a clinically meaningful and statistically significant reduction in the annualized rate of moderate-to-severe exacerbations compared to placebo across a broad spectrum of COPD patients exhibiting an eosinophilic phenotype. Preventing such exacerbations is a critical objective in COPD management, as they are known to cause irreversible lung damage, worsen symptoms, and increase mortality. Importantly, the incidence of adverse events was comparable between the mepolizumab and placebo groups in both studies.

Nucala distinguishes itself as the only approved biologic evaluated in patients with an eosinophilic phenotype defined by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL. BEC, easily measured via a simple blood test, serves as a biomarker for type 2 inflammation and indicates a patient’s risk of exacerbation. GSK highlights that approximately 70% of COPD patients in the U.S. who are inadequately controlled on inhaled triple therapy and continue to experience exacerbations have a BEC starting at 150 cells/μL and above. This translates to over one million individuals who could potentially benefit from adding mepolizumab to their current COPD treatment regimen, including those at risk of emergency department visits and/or hospitalizations.

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, commented, “The approval of Nucala in the US provides an important option for COPD patients. 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.”

In both MATINEE and METREX trials, mepolizumab, when added to triple inhaled therapy, significantly reduced the annualized rate of moderate or severe exacerbations compared with placebo. While a pre-defined secondary endpoint in MATINEE showed a reduction in COPD exacerbations requiring ED visits and/or hospitalization in the mepolizumab group, this result did not achieve statistical significance due to the pre-defined statistical testing hierarchy.

Currently, mepolizumab’s use in COPD is approved only in the U.S., with regulatory submissions presently under review in China and Europe.

FDA Greenlights GSK’s Nucala for Eosinophilic COPD

The U.S. Food and Drug Administration (FDA) approved GSK’s Nucala (mepolizumab) as an add-on treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval is based on positive results from MATINEE and METREX Phase III trials, which showed Nucala reduced exacerbations in patients with a blood eosinophil count (BEC) ≥150 cells/µL. The drug is now available in the U.S., with regulatory submissions ongoing in China and Europe.