Health
Nucala (mepolizumab) approved in Canada for use in adults with chronic obstructive pulmonary disease (COPD)
GSK announced today that Health Canada has approved Nucala (mepolizumab) as an add-on maintenance treatment in adult patients with COPD characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
About this update from Gsk Plc
MISSISSAUGA, ON, June 2, 2026 /CNW/ - GSK announced today that Health Canada has approved Nucala (mepolizumab) as an add-on maintenance treatment in adult patients with COPD characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA). Health Canada's approval was based on data from the MATINEE, METREX and METREO Phase III trials. In MATINEE and METREX, Nucala showed a statistically significant reduction in the annualized rate of moderate/severe exacerbations versus placebo in a COPD patient population with raised blood eosinophils (MATINEE: rate ratio [RR], 0.79; 95% confidence interval [CI], 0.66 to 0.94) (METREX: rate ratio, 0.82; 95% CI, 0.68 to 0.98).1,2 In METREO, Nucala demonstrated a numerical reduction in moderate/severe exacerbations compared to placebo, consistent with what was shown in METREX and MATINEE, although not statistically significant after adjusting for multiplicity. This was in addition to inhaled triple therapy (a combination of inhaled corticosteroid, long-acting beta agonist and long-acting antimuscarinic antagonist). In a pre-defined secondary endpoint in MATINEE, the annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization was numerically reduced in the Nucala group compared with placebo but did not meet statistical significance (rate ratio [RR] of 0.65; 95% CI: 0.43, 0.96).1 Preventing exacerbations is a key goal of COPD management.3,6 Exacerbations, especially those that lead to emergency department (ED) visits or hospitalizations, are devastating for patients and are known to cause irreversible lung damage, worsening of symptoms and increased mortality.3 COPD remains a major healthcare challenge in Canada, ranking consistently as the most common cause of unplanned hospitalization in Canada, along with bronchitis.4 Nucala is the only approved biologic whose efficacy at reducing hospitalization and ED visits was evaluated as a pre-defined secondary endpoint.1,2 "At GSK Canada, we understand the daily challenges faced by COPD patients and the heavy toll that exacerbations can take on their lives," says Dr. Michelle Horn, Country Medical Director, GSK Canada. "The approval of Nucala for COPD is about bringing hope and t...