Nucala is one step closer to being approved as a treatment for certain types of COPD in Europe. The European Medicines Agency (EMA) has given the thumbs-up to Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled COPD.
According to a press release, the recommendation is for COPD characterized by raised blood eosinophils in patients who are on a combination of inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist.
The positive opinion, from the Committee for Medicinal Products for Human Use (CHMP), is seen as the last step toward final approval of the treatment in Europe. The European Commission decision on an approval is expected in early 2026.
The drug’s manufacturer, GSK, said the positive opinion was based on data from the MATINEE phase 3 trial, published in the New England Journal of Medicine. In that trial, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate to severe exacerbations, compared to a placebo.
The MATINEE trial was also cited by the U.S. Food and Drug Administration (FDA) in May 2025 when it approved Nucala for use in adults with COPD. That approval made the United States the first country in the world to approve the drug.
Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development for GSK, praised the opinion.
“[The] CHMP recommendation brings us closer to providing Nucala to patients who are in need of new options,” he said.
