EU approves GSK’s Nucala (mepolizumab) for eosinophilic COPD patients uncontrolled on triple therapy. Phase III MATINEE data shows reduced exacerbations. First biologic option.
Written By: Pharmacally Medical News Desk
Following the recent positive opinion from the CHMP, the European Commission has now granted marketing authorisation for Nucala (mepolizumab) from GlaxoSmithKline as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with elevated blood eosinophils.
The approval applies to patients who continue to experience exacerbations despite receiving optimised inhaled triple therapy, including an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist. It formalises the CHMP’s earlier recommendation and allows Nucala to be marketed for this COPD population across the European Union.
Kaivan Khavandi, SVP at GlaxoSmithKline, said the EU approval gives patients with eosinophilic COPD access to the first monthly biologic shown to significantly cut exacerbations, helping reduce lung damage, hospitalisations, and emergency visits for those not controlled on inhaled triple therapy.
The decision is based on data from the Phase III MATINEE study (NCT04133909), which showed that mepolizumab reduced the annual rate of moderate to severe COPD exacerbations compared with placebo when added to standard care. Benefits were also observed in reducing exacerbations that led to hospitalisation or emergency department visits, with a safety profile consistent with Nucala’s established use in other eosinophilic conditions.
Nucala is a monoclonal antibody that targets interleukin-5, a key driver of eosinophilic inflammation. By lowering eosinophil levels, the therapy aims to reduce inflammation associated with frequent COPD exacerbations in a defined subgroup of patients.
Susanna Palkonen of the European Federation of Allergy and Airways Diseases Patients’ Associations welcomed the approval, highlighting the heavy burden of COPD on patients and the urgent need for new treatment options, especially for those with frequent exacerbations and repeated hospital stays.
With this approval, Nucala becomes one of the first biologic therapies authorised in the EU for COPD patients with an eosinophilic phenotype, expanding treatment options beyond inhaled therapies for those who remain inadequately controlled.
For full prescribing details and approved product information, see the Nucala (mepolizumab) European Public Assessment Report (EPAR) product information from the European Medicines Agency:
Reference
Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease (COPD), 06 February 2026, nucala-approved-by-the-european-commission.pdf
Nucala SmPC, https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
Mepolizumab as Add-on Treatment IN Participants with COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE), ClinicalTrials.gov ID NCT04133909, https://clinicaltrials.gov/study/NCT04133909