The European Commission (EC) has approved Nucala (mepolizumab), a monoclonal antibody developed by GSK, as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This landmark approval, announced on February 6, 2026, makes mepolizumab the first monthly biologic authorized in the European Union for this specific COPD phenotype. The decision expands the therapeutic reach of the interleukin-5 (IL-5) antagonist into its fifth European indication, addressing a significant unmet need for patients who remain symptomatic despite standard-of-care inhaled triple therapy.

Nucala is administered as a 100 mg subcutaneous injection every four weeks. In the EU, the therapy is indicated for adult patients who are currently managed on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). The US FDA previously approved mepolizumab for this indication in May 2025. The EC’s decision follows a recommendation from the Committee for Medicinal Products for Human Use (CHMP) issued in December 2025.

The approval is primarily supported by data from the MATINEE trial, a Phase III randomized, double-blind, parallel-group study. The trial evaluated the efficacy and safety of a 100 mg dose of mepolizumab as an add-on therapy in 804 patients with uncontrolled COPD and a blood eosinophil count of ≥300 cells/µL. The primary endpoint was the annualized rate of moderate or severe exacerbations over a treatment period of 52 to 104 weeks. Data showed that mepolizumab achieved a 21% reduction in the annualized rate of moderate/severe exacerbations compared to placebo (rate ratio 0.79; 95% CI 0.66–0.94; P=0.01). Furthermore, a pre-specified secondary endpoint demonstrated a 35% reduction in exacerbations requiring emergency department visits or hospitalizations. The safety profile was consistent with previous studies, with common adverse events including headache and injection site reactions.

Mepolizumab is a humanized monoclonal antibody that targets IL-5, a cytokine essential for the production and activation of eosinophils. While COPD is traditionally viewed as a neutrophilic disease, approximately 20%-40% of patients exhibit an eosinophilic (Type 2) inflammatory profile, which is associated with an increased risk of frequent and severe exacerbations. By neutralizing IL-5, mepolizumab reduces the systemic eosinophil burden, thereby decreasing the inflammatory drivers that lead to lung damage and acute symptom worsening. Originally approved in 2015 for severe eosinophilic asthma, the molecule’s clinical history now spans five indications, including chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).

The authorization of Nucala adds to a growing field of targeted biologics entering the COPD landscape. It joins a competitive environment that recently saw the UK and EU approval of Dupixent (dupilumab), an IL-4/IL-13 inhibitor developed by Sanofi and Regeneron, for a similar COPD population. Other assets in the clinical pipeline include AstraZeneca’s Fasenra (benralizumab), an IL-5 receptor alpha-directed antibody, which is currently undergoing Phase III evaluation for COPD.