GSK plc 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). 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. COPD affects over 390 million people, including about 40 million in Europe.

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. The MATINEE trial studied mepolizumab in a wide spectrum of patients with an eosinphilic 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).

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 Medicinein April 2025 with further data presented at the 2025 American Thoracic Society International Congress. In addition to COPD,Nucalais 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 use in Europe across five indications, including severe asthma, CRSwNP, EGPA, HES and COPD.