The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on maintenance for individuals with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
If approved, the monoclonal antibody is expected to become the initial monthly-dosed biologic for COPD.
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GSK’s application is underpinned by the positive outcomes from the Phase III MATINEE trial, which demonstrated a significant decrease in the annualised rate of moderate/severe exacerbations in patients treated with the antibody against a placebo.
The trial encompassed a broad range of COPD phenotypes and clinical presentations, suggesting that the antibody could provide substantial benefits when used alongside inhaled maintenance therapies.
Mepolizumab targets interleukin-5 (IL-5) and has already gained approval for four IL-5-mediated conditions in Europe.
These indications cover severe refractory eosinophilic asthma, for which the antibody is used as an add-on treatment in the adult, adolescent and paediatric population aged six years and above.
It is also indicated for use as an add-on treatment alongside intranasal corticosteroids for chronic rhinosinusitis with nasal polyps in adults.
Mepolizumab is intended for individuals aged six years and above with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), and for adults who have no adequate control of hypereosinophilic syndrome with no identifiable non-haematologic secondary cause.
Despite its established use in other conditions, the antibody is not yet approved for COPD treatment in any nation.
The mepolizumab programme of the company in COPD includes three studies, with the METREX and METREO trials concluded in 2017.
The Phase III MATINEE trial assessed the safety and efficacy of the antibody as an add-on therapy to inhaled triple therapy in individuals with a history of exacerbations and elevated counts of blood eosinophils.
In January 2025, the European Commission approved the company’s Jemperli in conjunction with chemotherapy for the first-line treatment of primary advanced or recurrent endometrial cancer in the adult population.
