GSK's Nucala Advances Toward EU Nod for Uncontrolled COPD

GSK Nucala has moved a step closer to European approval after the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for adults with uncontrolled COPD marked by raised blood eosinophils.

The biologic is intended as an add-on maintenance treatment for patients already using inhaled triple therapy with ICS, LABA, and LAMA. A final decision from the European Commission is expected in Q1 2026.

The CHMP opinion positions GSK Nucala as a potential new option for a subgroup of COPD patients who continue to suffer frequent flare-ups despite optimized inhaled treatment. These exacerbations often lead to hospital visits, permanent lung damage, and rising healthcare costs across Europe.

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Kaivan Khavandi, SVP & global head, respiratory, immunology & inflammation R&D, GSK said: “People living with uncontrolled COPD with an eosinophilic phenotype continue to experience exacerbations that can lead to irreversible lung damage and avoidable hospitalizations and emergency department visits. Preventing these events is crucial to slowing the progression of disease and today’s CHMP recommendation brings us closer to providing Nucala to patients who are in need of new options.”

The recommendation is based on results from the phase III MATINEE trial, where mepolizumab significantly reduced moderate or severe COPD exacerbations compared with placebo when added to triple therapy. The drug also showed a meaningful reduction in exacerbations requiring emergency department visits or hospitalization, a first for a biologic in a phase III COPD study. Safety results were comparable to placebo.

COPD affects over 40 million people in Europe and remains a major cause of death and healthcare strain. With Nucala already approved for COPD in the U.S., GSK continues to expand its respiratory portfolio focused on targeted biologics and long-term disease control.