GSK Nucala receives positive EMA Committee opinion for COPD
London: GSK has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (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 European Commission decision on approval is expected in Q1 2026.
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said, “People living with uncontrolled COPD with an eosinophilic phenotype continue to experience exacerbations that can lead to irreversible lung damage and avoidable hospitalisations and emergency department visits. Preventing these events is crucial to slowing the progression of disease and today’s CHMP recommendation brings us closer to providing Nucala to patients who are in need of new options.”
COPD affects more than 40 million people in Europe and more than 390 million people globally. It is estimated that over 35% of COPD patients who are inadequately controlled on inhaled triple therapy have a raised blood eosinophil count (BEC) of at least 300 cells/μL. Recurrent exacerbations accelerate disease progression and add to pressure on healthcare systems through unplanned and unpredictable emergency department visits and inpatient care. In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in more than 330,000 deaths in Europe.
The positive opinion is based on data from the MATINEE phase III trial in which mepolizumab demonstrated a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo, both in addition to inhaled triple therapy [rate ratio 0.79, 95% confidence interval (0.66, 0.94), P=0.01] (AER mepolizumab = 0.80 exacerbations per year versus placebo = 1.01).6,7 The MATINEE trial studied mepolizumab in a wide spectrum of patients with an eosinophilic phenotype including chronic bronchitis, emphysema only or a combination of both. The incidence of adverse events were similar between mepolizumab and placebo (mepolizumab vs placebo: 74% vs 77%).
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).
Mepolizumab is a biologic with pre-specified phase III data showing a reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation versus placebo.
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