GSK announced a significant milestone in respiratory medicine as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Nucala (mepolizumab) for treating uncontrolled chronic obstructive pulmonary disease (COPD) in adults with elevated blood eosinophil levels. As reported by PharmaBiz.com, the European Commission is expected to make a final decision in the first quarter of 2026.
Nucala, a monoclonal antibody that targets interleukin-5 (IL-5), represents an important advancement for COPD patients who remain symptomatic despite receiving triple inhaled therapy, the current gold standard combining an inhaled corticosteroid, long-acting beta2-agonist, and long-acting muscarinic antagonist. The condition’s burden is substantial: COPD affects over 40 million people in Europe and approximately 390 million globally, with an estimated 35% of inadequately controlled patients exhibiting elevated blood eosinophil counts of at least 300 cells/µL.
The positive recommendation stems from compelling data from the MATINEE phase III trial, which evaluated mepolizumab in 804 COPD patients with type 2 inflammation. The study demonstrated that mepolizumab administration via subcutaneous injection every four weeks significantly reduced the annualized rate of moderate to severe exacerbations compared with placebo. Specifically, mepolizumab-treated patients experienced 0.80 exacerbations per year versus 1.01 in the placebo group (rate ratio 0.79, p=0.01). Importantly, the treatment was well-tolerated, with adverse event incidence similar between groups (74% versus 77%).
A particularly notable finding from MATINEE involved exacerbations requiring emergency department visits or hospitalization. Mepolizumab reduced the annualized rate of these severe events to 0.13 per year compared with 0.20 for placebo, making it the first biologic therapy with pre-specified phase III data demonstrating this benefit. This distinction is clinically meaningful, as recurrent exacerbations accelerate disease progression and create substantial healthcare burdens through unplanned emergency visits and hospitalizations.
The trial’s scope was comprehensive, enrolling patients with varying COPD presentations including chronic bronchitis, emphysema, or both, with disease severity ranging from moderate to very severe (GOLD stages 2-4). All participants had experienced exacerbations despite optimized maintenance therapy, representing the population most in need of additional treatment options.
According to Kaivan Khavandi, SVP and global head of respiratory, immunology and inflammation R&D at GSK, “People living with uncontrolled COPD with an eosinophilic phenotype continue to experience exacerbations that can lead to irreversible lung damage and avoidable hospitalisations.” The approval would provide patients with new therapeutic options to slow disease progression.
This approval would mark Nucala’s fifth indication across its portfolio. The drug is already approved in Europe for severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. The U.S. Food and Drug Administration granted approval for COPD in May 2025.
