The European Commission has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterised by raised blood eosinophils, marking a significant expansion of treatment options for COPD patients in the European Union.
The approval applies to patients who continue to experience symptoms despite treatment with inhaled triple therapy, including an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. Nucala, a monoclonal antibody targeting interleukin-5, becomes the first and only monthly biologic in the EU to be evaluated across a broad COPD population with an eosinophilic phenotype.
The decision was based on results from the phase III MATINEE trial, which demonstrated a clinically meaningful and statistically significant reduction in the annualised rate of moderate and severe COPD exacerbations compared with placebo when added to standard of care. In the trial, mepolizumab reduced exacerbations to 0.80 per year versus 1.01 with placebo.
The study also showed a reduction in exacerbations requiring emergency department visits and/or hospitalisation, with an annualised rate of 0.13 per year in the mepolizumab group compared with 0.20 in the placebo group. Safety outcomes were comparable between treatment arms.
MATINEE evaluated mepolizumab in a wide spectrum of patients with an eosinophilic COPD phenotype, including those with chronic bronchitis, emphysema, or a combination of both. Full trial results were published in The New England Journal of Medicine in April 2025, with additional data presented at the American Thoracic Society International Congress in 2025.
COPD affects more than 390 million people worldwide, including around 40 million in Europe, and is projected to become the leading cause of hospital admissions globally over the next decade. Hospitalisation due to COPD is associated with high mortality, both during admission and in the years following discharge.
In addition to COPD, Nucala is approved in Europe for several other conditions associated with type 2 inflammation, including severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. The therapy has also received regulatory approval for COPD in the United States, the United Kingdom and China.
