MHRA authorises Nucala (mepolizumab) in the UK for the treatment of uncontrolled COPD of an eosinophilic phenotype for patients on triple therapy*

·         The approval is based on two placebo-controlled phase 3 studies, which showed mepolizumab significantly reduced the annualised rate of moderate/severe exacerbations and time to first moderate/severe exacerbation once commenced on treatment.[i]

·         The MATINEE trial, published in the New England Journal of Medicine is the first biologic study in a wide population of Chronic Obstructive Pulmonary Disease (COPD) patients with an eosinophilic phenotype on *a combination of an inhaled corticosteroid (ICS), a long acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).1

·         The safety and tolerability profile for mepolizumab was consistent with the known profile of the medicine.1

·         The National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) will now review mepolizumab for reimbursement.

GSK plc (LSE/NYSE: GSK) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), as an add-on maintenance biologic treatment for adult patients with uncontrolled COPD of an eosinophilic phenotype on a combination of an inhaled corticosteroid (ICS), a long acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).

Professor Mona Bafadhel, Director of King’s Centre for Lung Health and Chair of Respiratory Medicine at King’s College London said: “For people living with COPD, managing exacerbations is an ongoing challenge that significantly impacts their lives, with almost a quarter of hospitalised patients being re-admitted within 30 days.[ii] The approval of mepolizumab provides us with a new treatment option that can help people with eosinophilic COPD by reducing the frequency of their exacerbations.”

Dr Joanne Hunt, Medical Head, Specialty, GSK UK, said: “At GSK, we’re committed to redefining respiratory care through innovation. If recommended by the National Institute for Health and Care Excellence (NICE), mepolizumab will be administered every 4 weeks to significantly reduce the rate of moderate/severe exacerbations and delay the time to first moderate/severe exacerbation once commenced on treatment.”

MHRA approval was granted on December 29th 2025.

COPD is the name for a group of lung conditions that occur when the lungs and airways become damaged and inflamed.[iii] The condition includes emphysema (damage to the air sacs in the lungs) and chronic bronchitis (long-term inflammation on the airways). Symptoms can include breathlessness, a persistent cough with phlegm, frequent chest infections and persistent wheezing.[iv]

An estimated three million people in the UK have COPD, with a large proportion of these remaining undiagnosed.[v] COPD is the second most common cause of emergency hospital admissions in the UK, with one person admitted every three minutes.[vi] It is also a leading cause of hospital re-admissions, with 24% re-admitted within 30 days of discharge and 43% re-admitted within 90 days, placing a substantial burden on individuals, the NHS, and society.2 COPD care costs the NHS approximately £2 billion each year,[vii] with each hospital admission costing an average of £5,775 per patient.[viii] As the number of people living with COPD in England is projected to rise by 40% by 2030, related healthcare costs are expected to reach £2.5 billion annually,[ix] with 45% attributed to exacerbations and 55% to ongoing disease management.7

The approval is based on data from the positive MATINEE and METREX phase III trials of mepolizumab in COPD.1,[x]  These trials included patients with a clinically documented history of COPD for at least 1 year, in accordance with the definition by the American Thoracic Society/European Respiratory Society.10

In both MATINEE and METREX, mepolizumab with triple therapy showed a statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo (triple inhaled therapy alone), 21% and 18% respectively, in patients with eosinophilic COPD meeting the primary endpoint for the trials. MATINEE (rate ratio [95% confidence interval (CI)]: 0.79 [0.66, 0.94]; P=0.011) (annualised exacerbation rate (AER) mepolizumab = 0.80 exacerbations per year versus placebo = 1.01) n= 804; mepolizumab = 403, placebo = 401) and METREX (rate ratio [95% CI]: 0.82 [0.68, 0.98]; P=0.036) (AER mepolizumab = 1.40 exacerbations per year versus placebo = 1.71) n= 462; mepolizumab = 233, placebo = 229)1,10

In both trials, mepolizumab showed a statistically significant reduction in patients’ time to first moderate/severe exacerbation once commenced on treatment. The median time to first moderate/severe exacerbation was longer in the mepolizumab-treated group (MATINEE 419 days, MEXTREX 192 days) versus the placebo-treated group (MATINEE 321 days, METREX 141 days), reducing time to first exacerbation by 98 days and 51 days respectively.1,10

In MATINEE a 35% reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation was shown with mepolizumab versus placebo, a secondary endpoint (rate ratio [95% CI]: 0.65 [0.43, 0.96] not statistically significant due to a failure of an endpoint higher in the pre-defined statistical testing hierarchy) (AER mepolizumab = 0.13 exacerbations per year versus placebo = 0.20).1

Safety results in both studies were generally consistent with the known safety profile of mepolizumab in its approved indications. The most common side effects, across indications, include headache, lower respiratory tract infection, urinary tract infection, pharyngitis, herpes zoster, hypersensitivity reactions, nasal congestion, abdominal pain upper, eczema, back pain, arthralgia, administration-related reactions, local injection site reactions and pyrexia. In placebo-controlled studies in patients with COPD, the most commonly reported adverse reactions during treatment were headache (10%), back pain (7%) and arthralgia (5%).[xi]

NICE is expected to make a decision on mepolizumab for COPD in 2026. The Scottish Medicines Consortium (SMC) will also be reviewing mepolizumab for COPD.

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

MATINEE assessed the efficacy and safety of mepolizumab for 52–104 weeks, in 804 patients with COPD with evidence of type 2 inflammation, characterised by a 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 condition of patients ranged in severity from moderate to very severe, or stages 2-4 as assessed by the medically recognised scale of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2026 Report.[xii] 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 The safety profile was comparable between groups, with no new safety concerns.1

About METREX

METREX is a phase III, randomized (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). METREX evaluated the intervention over 52 weeks in 836 patients with moderate to very severe COPD (GOLD 2–4) who continued to exacerbate despite optimized inhaled maintenance therapy. Enrollment included patients with or without evidence of type 2 inflammation, with subgroup stratification based on blood eosinophil counts (≥ 150 cells/µL at screening or ≥ 300 cells/µL in the prior year). Among 462 patients with an eosinophilic phenotype, mepolizumab reduced the annual rate of moderate or severe exacerbations to 1.40 per year versus 1.71 per year with placebo (rate ratio 0.82; 95% CI 0.68–0.98; adjusted P = 0.04). No significant difference was seen in the overall population. The safety profile was comparable between groups, with no new safety concerns.10

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 has received marketing authorisation in the UK and Europe across four indications - severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

For product and important safety information please consult the country’s relevant summary of product characteristics. The EU and UK 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.