GSK has received the US Food and Drug Administration (FDA) expanded approval for Nucala (mepolizumab) to treat a type of chronic obstructive pulmonary disease (COPD).
Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a cytokine involved in type 2 inflammation and is already approved in Europe and the US for IL-5-mediated conditions.
FDA approved the drug as an add-on maintenance treatment in adults with chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
It is a significant development for patients with inadequately controlled COPD, as Nucala is the first biologic approved for this specific patient group.
GSK SVP, respiratory, immunology and inflammation R&D global head Kaivan Khavandi said: “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.”
The FDA decision was supported by data from the MATINEE and METREX Phase 3 trials, which showed a significant reduction in the rate of exacerbations compared to placebo.
MATINEE involved 804 patients over 52–104 weeks, while METREX included 836 patients over 52 weeks, focusing on both eosinophilic and non-eosinophilic phenotype groups.
The studies assessed the efficacy and safety of mepolizumab 100 mg as an add-on therapy, administered subcutaneously every four weeks, alongside optimal inhaled triple therapy.
In the two trials, Nucala was the only biologic tested in patients with an eosinophilic phenotype, identified by a blood eosinophil count (BEC) of ≥150 cells/µL.
BEC, determined through a simple blood test, serves as a biomarker for type 2 inflammation and helps assess a patient’s risk of exacerbation.
The MATINEE trial also showed that it reduced the annualised rate of COPD exacerbations requiring emergency department visits or hospitalisation compared to placebo.
Currently, GSK’s regulatory submissions for Nucala in COPD are under review in China and Europe.
COPD Foundation CEO Jean Wright said: “COPD isn’t just a disease, it’s a relentless cycle. 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.”
