GSK announces European Commission approved Nucala

GSK (GSK) announced the European Commission has approved Nucala, a monoclonal antibody targeting interleukin-5, in adults as an add-on maintenance treatment for uncontrolled COPD characterized by raised blood eosinophils on a combination of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist. The approval was based on data from the positive MATINEE phase III trial in which mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype.