GSK plc (LON:GSK, NYSE: GSK) has announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).
· Approval based on results from MATINEE showing significant reduction in the rate of moderate/severe exacerbations versus placebo
· Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
· MATINEE data showed a reduction in exacerbations leading to emergency department visits and/or hospitalisations versus placebo
The approval was based on data from the positive MATINEE phase III trial in which mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype.1
COPD affects over 390 million people, including about 40 million in Europe.2,3 Globally, it is projected to be the leading cause of hospital admissions over the next decade.4 If hospitalised due to COPD, one in ten patients will die during the stay, up to one in four over the next year and half will lose their lives within five years.5,6 Nucala is the first biologic with pre-specified phase III data showing a reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation versus placebo.1
Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage, hospitalisations and emergency department visits. Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD.”
Susanna Palkonen, Director, European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), said: “The burden for patients living with COPD is immense, especially for those facing continued exacerbations and repeated hospitalisations. We welcome, and our community celebrates, new treatment options for COPD patients as they are desperately needed.”
In MATINEE, mepolizumab demonstrated a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo, both in addition to inhaled triple therapy [rate ratio 0.79, 95% confidence interval (0.66, 0.94), P=0.01] (AER mepolizumab = 0.80 exacerbations per year versus placebo = 1.01).1 The MATINEE trial studied mepolizumab in a wide spectrum of patients with an eosinophilic phenotype including chronic bronchitis, emphysema only or a combination of both.
In a pre-defined secondary endpoint, the annualised rate of COPD exacerbations requiring ED visits and/or hospitalisation was reduced in the mepolizumab group when compared with placebo [rate ratio 0.65; 95% CI (0.43, 0.96) nominally significant after adjustment for multiplicity] (AER mepolizumab = 0.13 exacerbations per year versus placebo = 0.20).1 The incidence of adverse events were similar between mepolizumab and placebo (mepolizumab vs placebo: 74% vs 77%). The full results from the MATINEE phase III trial were published in The New England Journal of Medicine in April 2025 with further data presented at the 2025 American Thoracic Society International Congress.1
In addition to COPD, Nucala is approved in Europe across four other diseases driven by underlying type 2 inflammation, including severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It has also been approved for COPD in the US, UK, and China.
References
1 Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. Apr 2025;392:1710-1720. Available at https://www.nejm.org/doi/10.1056/NEJMoa2413181
2 Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2026 Gold Report. Available at: https://goldcopd.org/2026-gold-report-and-pocket-guide/. Last accessed November 2025.
3 European Respiratory Society. (2023). Introductions. https://www.ersnet.org/wp-content/uploads/2023/01/Introductions.pdf
4 Khakban, Amir et al. “The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective.” American journal of respiratory and critical care medicine vol. 195,3 (2017): 287-291. doi:10.1164/rccm.201606-1162PP. Accessed April 2025.
