GSK Gets EU Approval for Expanded Use of Nucala in COPD

Core Insights - GSK plc announced the European Commission's approval of its respiratory drug Nucala (mepolizumab) for treating certain patients with chronic obstructive pulmonary disease (COPD), marking a new indication for the drug [1] Group 1: Drug Approval and Indications - Nucala is now approved as an add-on maintenance treatment for uncontrolled COPD in adults with a raised blood eosinophil count, in combination with an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist in the European Union [2] - The approval was anticipated following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2025 [2] - Nucala is the first and only monthly biologic in the EU studied in a broad group of COPD patients with an eosinophilic phenotype [3][7] Group 2: Clinical Data and Efficacy - The approval for Nucala in the EU was based on positive data from the phase III MATINEE study, which showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate/severe exacerbations compared to placebo plus standard of care [8] - Data from the MATINEE study also indicated that Nucala treatment led to a reduction in exacerbations resulting in emergency department visits and/or hospitalizations [9] - Exacerbations are acute episodes of worsening COPD symptoms that can lead to hospitalization and irreversible lung damage, making their prevention a key goal in managing COPD [9] Group 3: Market Impact and Financial Performance - COPD affects over 390 million people globally, including about 40 million in Europe, and is one of the leading causes of hospitalization worldwide [10] - Nucala is a monoclonal antibody targeting IL-5, a key messenger protein in type 2 inflammation, and is also approved for four other IL-5-mediated conditions [11] - Nucala generated sales of £2.01 billion in 2025, reflecting a 15% year-over-year increase at constant exchange rates, and remains a key top-line driver for GSK [11] Group 4: Stock Performance - Over the past six months, GSK's shares have surged by 57.5%, outperforming the industry's rally of 43.5% [4]