GSK plc has announced that National Institute for Health and Care Excellence has issued draft final guidance recommending Nucala (mepolizumab) for use on the NHS as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) who have raised blood eosinophils and are already receiving triple inhaled therapy.

The recommendation is based on a clinical evidence package including the Phase III MATINEE, METREX and METREO trials, which evaluated mepolizumab in patients with COPD characterised by an eosinophilic phenotype despite optimised inhaled treatment. Across these studies, results showed a reduction in moderate and severe exacerbations compared with placebo, alongside delayed time to first exacerbation.

In MATINEE, mepolizumab added to inhaled triple therapy significantly reduced the annualised rate of moderate or severe exacerbations compared with placebo. Time to first exacerbation was also extended, reflecting a slower disease progression in treated patients within the study population. Safety findings were broadly consistent with the established profile of mepolizumab across its existing indications.

The NHS decision is particularly focused on patients whose COPD remains uncontrolled despite standard triple therapy combining an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. Treatment is administered as a once-monthly subcutaneous injection, with options for self-administration or delivery via a healthcare professional or trained caregiver.

Sarah Sleet, chief executive of Asthma + Lung UK, said: “Today’s NICE decision, to recommend the use of mepolizumab on the NHS for people with uncontrolled chronic obstructive pulmonary disease (COPD), is a significant milestone for COPD treatment.”

She added that while the therapy could reduce exacerbation risk and improve quality of life, “only some people with uncontrolled COPD will be eligible for this treatment so more research is still needed to uncover new treatments for the condition.”

COPD remains a major respiratory burden in the UK, affecting an estimated three million people, with two million believed to be undiagnosed. The condition is a leading cause of emergency hospital admission and readmission, with exacerbations driving a significant proportion of healthcare utilisation and costs.

Professor Richard Russell of King’s College London said the availability of Nucala for eligible NHS patients “offers a new biologic treatment option” and may help reduce exacerbations that can lead to hospitalisation and long-term deterioration.

The MATINEE trial enrolled 804 patients with eosinophilic COPD and showed a statistically significant reduction in annualised exacerbation rates compared with placebo, alongside a delayed time to first event. Similar signals were seen in METREX, particularly in eosinophilic subgroups, reinforcing the biological rationale for targeting type 2 inflammation in COPD.

Dr Joanne Hunt, medical head, specialty at GSK UK, said the decision “further reinforces that GSK is committed to redefining respiratory care through innovation” and highlighted that reducing exacerbations remains central to improving outcomes for patients and pressure on health systems.

COPD care costs the NHS around £2 billion annually, with exacerbations accounting for a large proportion of spending. With prevalence projected to rise over the next decade, NICE’s recommendation may mark a shift towards biologic therapies for a defined inflammatory subtype of COPD.

The Scottish Medicines Consortium will also review mepolizumab for COPD, potentially expanding UK-wide access pending further assessment.

Overall, this development reflects a broader move towards phenotype-driven treatment in respiratory disease, where biologics are increasingly used to target specific inflammatory pathways rather than treating COPD as a single uniform condition.