GSK application to expand use of Nucala to COPD accepted for review by EMA

GSK (GSK) plc announced that the European Medicines Agency has accepted for review its application to expand the use of Nucala, a monoclonal antibody that targets interleukin-5, as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype. “The application is supported by results from the positive phase III MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations with mepolizumab compared to placebo. The trial recruited patients across a wide spectrum of COPD phenotypes and clinical presentations. These data indicate that mepolizumab, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. Results of MATINEE will be presented at a future scientific congress,” GSK stated.