Application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency - GSK

GSK plc  announced that the EMA has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) 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.

If approved, mepolizumab could be the first biologic with monthly dosing for patients with COPD.

MATINEE is a phase III, randomized (1:1), double-blind, parallel-group trial assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy, administered subcutaneously every 4 weeks for 52–104 weeks, versus placebo in addition to inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid) in 804 patients with COPD, a history of exacerbations, and evidence of type 2 inflammation characterised by raised blood eosinophil count.

The primary endpoint was met with the addition of Nucala to inhaled maintenance therapy, showing a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.