European Commission Approves GSK’s Nucala as First Monthly Biologic for Uncontrolled Eosinophilic COPD in the EU

European Commission Approves GSK’s Nucala as First Monthly Biologic for Uncontrolled Eosinophilic COPD in the EU

(IN BRIEF) GSK announced that the European Commission has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults in the EU with uncontrolled COPD characterised by raised blood eosinophils who are already receiving inhaled triple therapy, making it the first monthly biologic evaluated in a broad COPD population with an eosinophilic phenotype. The decision is supported by results from the phase III MATINEE trial, which showed a clinically meaningful and statistically significant reduction in moderate and severe exacerbations versus placebo, including fewer episodes leading to emergency department visits and hospitalisations, with a safety profile comparable to placebo. The approval addresses a major unmet need in a disease affecting more than 390 million people globally and around 40 million in Europe, where many patients continue to experience exacerbations despite standard therapy, while reinforcing GSK’s broader respiratory strategy as Nucala is already authorised across multiple other type 2 inflammatory conditions and in several major markets outside the EU.

(PRESS RELEASE) LONDON, 6-Feb-2026 — /EuropaWire/ — GSK plc announced that the European Commission has granted approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by elevated blood eosinophil levels and already receiving inhaled triple therapy. The decision marks a significant milestone in the treatment landscape for COPD in the European Union, making Nucala the first monthly biologic assessed in a broad COPD population with an eosinophilic phenotype.

The regulatory approval is supported by findings from the pivotal phase III MATINEE trial, which demonstrated that mepolizumab achieved a clinically meaningful and statistically significant reduction in the annual rate of moderate and severe COPD exacerbations compared with placebo when added to standard of care. The data indicated that treatment with Nucala also reduced the frequency of exacerbations leading to emergency department visits and hospitalisations, underscoring its potential to address some of the most serious consequences of the disease.

COPD remains a major global health burden, affecting more than 390 million people worldwide, including approximately 40 million across Europe. It is projected to become the leading cause of hospital admissions over the coming decade. For patients hospitalised due to COPD, the risk of mortality is substantial, with significant proportions facing life-threatening outcomes within one year and five years of admission. In this context, Nucala represents a new therapeutic option for patients who continue to experience exacerbations despite receiving inhaled triple therapy.

Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK, highlighted that this approval provides, for the first time in the EU, a targeted monthly biologic option for adults with uncontrolled COPD driven by elevated blood eosinophils. He emphasised that Nucala has the potential to reduce exacerbations that can lead to irreversible lung damage, hospitalisations, and emergency department visits, offering additional support for patients who require more than existing inhaled treatments.

Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients’ Associations, welcomed the approval, noting the immense burden faced by individuals living with COPD, particularly those who experience repeated exacerbations and hospitalisations. She described the availability of new treatment options as a critical development for the patient community.

In the MATINEE trial, mepolizumab achieved a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo when used alongside inhaled triple therapy, with a rate ratio of 0.79. The study included a diverse population of patients with an eosinophilic phenotype, encompassing those with chronic bronchitis, emphysema, or a combination of both conditions.

A pre-specified secondary analysis also showed that mepolizumab reduced the annualised rate of exacerbations requiring emergency department visits or hospitalisation, with a rate ratio of 0.65 compared with placebo. The overall incidence of adverse events was comparable between the treatment and placebo groups. Full results from the MATINEE trial were published in The New England Journal of Medicine in April 2025, with additional data presented at the 2025 American Thoracic Society International Congress.

Beyond COPD, Nucala is already approved in Europe for four other conditions driven by type 2 inflammation, including severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. The treatment has also received approval for COPD in the United States, the United Kingdom, and China.

About COPD

COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema.2 It affects more than 390 million people globally and is the third leading cause of death.2,7 Patients with COPD experience persistent respiratory symptoms such as breathlessness, cough, and sputum along with progressive airflow obstruction due to the chronic inflammation, that impact daily life.2

Despite inhaled triple therapy, many patients experience persistent symptoms and exacerbations.8 A proportion of these patients have elevated type 2 inflammation, characterised by raised BEC. This inflammation contributes to the higher risk of exacerbations, or acute episodes of worsening COPD symptoms, which can result in hospitalisation and irreversible lung damage.2 Early intervention is important in preventing exacerbations and cumulative lung damage.2

About MATINEE

MATINEE is a phase III, randomised (1:1), double-blind, parallel-group trial assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy, administered subcutaneously every 4 weeks versus placebo in addition to optimal inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid).1,8 MATINEE assessed the efficacy and safety of mepolizumab in patients with COPD with evidence of type 2 inflammation, characterised by a raised blood eosinophil count (≥300 cells/µL). Patients could participate with a range of clinical presentations of COPD including chronic bronchitis, emphysema only or a combination of both. The full analysis of MATINEE included 403 patients enrolled on the mepolizumab arm and 401 on placebo, all of whom had experienced exacerbations in the previous year despite receiving optimised inhaled maintenance therapy.1

About Nucala (mepolizumab)

Nucala is a monoclonal antibody that targets and binds to IL-5. Nucala has been developed for the treatment of a range of diseases with underlying type 2 inflammation. Nucala is approved for use in Europe across five indications, including severe asthma, CRSwNP, EGPA, HES and COPD.9

For product and important safety information please consult the country’s relevant summary of product characteristics. The EU Prescribing Information is available at: NUCALA-EPAR-PRODUCT-INFORMATION_EN.PDF

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q4 Results for 2025.

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.
5. Waeijen-Smit K, et al. Global mortality and readmission rates following COPD exacerbation-related hospitalisation: a meta-analysis of 65 945 individual patients. ERJ Open Res. 2024 Feb 26;10(1):00838-2023. doi: doi.org/10.1183/23120541.00838-2023
6. van Hirtum PV, et al. Long term survival after admission for COPD exacerbation: A comparison with the general population. Respir Med. 2018;137:77-82. doi:10.1016/j.rmed.2018.02.015
7. Chen S, et al. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023;11(8):e1183-e1193. DOI: 10.1016/S2214-109X(23)00217-6.
8. Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208.
9. European Medicines Authority. Nucala prescribing information. Available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. Last accessed January 2026.

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SOURCE: GlaxoSmithKline plc