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Nucala receives positive CHMP opinion for COPD
GSK plc announced that Nucala (mepolizumab) has received a positive opinion from the CHMP of the EMA for the treatment of uncontrolled chronic obstructive pulmonary disease (COPD) in adults with a raised blood eosinophil count, as an add-on maintenance treatment to inhaled triple therapy. This recommendation is based on the MATINEE phase III trial, which demonstrated a statistically significant reduction in COPD exacerbations, with a rate ratio of 0.79 compared to placebo. The European Commission decision is anticipated in Q1 2026, and Nucala could offer a new option for millions of Europeans with uncontrolled COPD and an eosinophilic phenotype. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 12 December 2025, London UK\n \nNucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease (COPD)\n \n· Positive opinion based on MATINEE phase III trial showing significant reduction in COPD exacerbations versus placebo in addition to inhaled triple therapy\n· Nucala is the only monthly biologic studied in a wide COPD population with an eosinophilic phenotype\n· Nucala could offer a new option to millions of Europeans who remain uncontrolled on inhaled triple therapy and have a raised blood eosinophil count\n \n \nGSK plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).\n \nThe European Commission decision on approval is expected in Q1 2026.\n \nKaivan 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 hospitalisations 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.\"\n \nCOPD affects more than 40 million people in Europe and more than 390 million people globally.1,2 It is estimated that over 35% of COPD patients who are inadequately controlled on inhaled triple therapy have a raised blood eosinophil count (BEC) of at least 300 cells/μL.3 Recurrent exacerbations accelerate disease progression and add to pressure on healthcare systems through unplanned and unpredictable emergency department visits and inpatient care.2,4 In 2021 alone, COPD had a societal cost of approximately 164 billion euros and resulted in ...