Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that the European Medicines Agency (EMA) has accepted its application to expand the use of Nucala (mepolizumab) for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
If approved, Nucala would become the first biologic with monthly dosing for COPD.
The submission is based on positive results from the Phase III MATINEE trial, which demonstrated a statistically significant reduction in moderate/severe exacerbations with mepolizumab versus placebo. COPD affects over 40 million people in Europe and is a leading cause of hospitalizations and mortality.
GSK continues to advance respiratory treatments, focusing on targeted biologics and inhaled therapies to address underlying disease mechanisms.
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