GSK plc has received European Commission approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by elevated blood eosinophils, despite treatment with inhaled triple therapy. The decision introduces the first biologic therapy in the European Union shown in phase III trials to significantly reduce exacerbations in this patient population.

The approval is based on results from the MATINEE phase III trial, where mepolizumab demonstrated a statistically significant and clinically meaningful reduction in the annualised rate of moderate to severe COPD exacerbations when added to standard care. Patients receiving the therapy experienced fewer flare-ups compared with placebo, including reductions in exacerbations requiring emergency department visits or hospitalisation. Safety findings were consistent with previous studies, with adverse event rates similar between treatment and placebo groups.

COPD affects more than 390 million people globally, including an estimated 40 million in Europe, and remains a leading cause of hospital admissions and mortality. Many patients continue to experience persistent symptoms and repeated exacerbations despite optimal inhaled therapy. A subset of these individuals exhibits type 2 inflammation marked by raised eosinophil counts, which is associated with higher exacerbation risk and progressive lung damage.

Mepolizumab targets interleukin-5, a key driver of eosinophilic inflammation, helping reduce the frequency and severity of disease flare-ups. GSK said the approval provides a new treatment option for patients whose disease remains uncontrolled, potentially lowering hospitalisation risk and slowing long-term lung damage.

Patient advocacy groups welcomed the decision, noting the heavy burden COPD places on individuals and healthcare systems. Clinical investigators added that biologic therapies tailored to inflammatory subtypes represent an important step toward more personalised respiratory care.

Nucala is already approved in Europe for several other type 2 inflammatory conditions, including severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. The therapy has also received COPD approvals in other global markets.

GSK said the milestone reflects its broader strategy to advance targeted biologic treatments and redefine care standards in respiratory disease through science-driven innovation.