EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD

Core Insights - GSK's Nucala has received acceptance for review by the European Medicines Agency for a new indication as an add-on maintenance treatment for COPD with an eosinophilic phenotype [1][5] - Nucala is currently approved for four IL-5-mediated conditions in Europe and is not yet approved for COPD globally [2][3] - If approved, Nucala would be the first biologic with a monthly dosing option for COPD patients in Europe [7] Company Performance - GSK's shares have increased by 16.1% year to date, outperforming the industry average rise of 5.7% [4] - Nucala generated sales of £1.78 billion in 2024, reflecting a 12% year-over-year increase at constant exchange rates, making it a key revenue driver for GSK [7] Clinical Data - The regulatory application for Nucala's COPD indication is based on positive results from the phase III MATINEE study, which demonstrated a significant reduction in the annualized rate of moderate/severe exacerbations compared to placebo [5]