The European Commission has approved the use of Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5) as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils.
The treatment is approved for adults who are on a combination of inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
According to a press release from drug manufacturer GSK, the approval was based on data from the MATINEE phase 3 trial. The study’s findings were outlined in the paper, “Mepolizumab to Prevent Exacerbations of COPD With an Eosinophilic Phenotype,” which was published in the New England Journal of Medicine.
In the trial, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate to severe COPD exacerbations compared to a placebo.
Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development for GSK, said the approval was a positive step forward for Europeans living with COPD.
“For the first time, adults with uncontrolled COPD characterized by raised blood eosinophils in the E.U. will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage,” he said.
In December 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the drug, paving the way for its approval by the European Commission.
Nucala was also approved as a treatment by the U.S. Food and Drug Administration in May 2025, making it the first country in the world to approve the drug.
