Health Canada has approved the use of Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils.
This news comes just months after the drug was approved by the European Commission and roughly a year after it was approved by the U.S. Food and Drug Administration.
The treatment is approved for patients whose COPD is inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
GlaxoSmithKline (GSK), the manufacturer of Nucala, said in a press release that the approval was based on data from the MATINEE, METREX and METREO phase 3 trials. The MATINEE findings were outlined in the paper, “Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype,” which was published in the New England Journal of Medicine. The results for METREO and METREX were outlined in the paper, “Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease,” published in 2017 in the New England Journal of Medicine.
In the MATINEE and METREX trials, Nucala showed a statistically significant reduction in the annualized rate of moderate-to-severe exacerbations compared with placebo in a COPD patient population with raised blood eosinophils.
A secondary endpoint in the MATINEE trial, the annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalizations was numerically reduced in the Nucala group compared to placebo. However, this did not meet statistical significance.
In METREO, Nucala demonstrated a numerical reduction in moderate-to-severe exacerbations compared to placebo, consistent with what was shown in the other two trials. However, this result was not statistically significant when adjusted for multiplicity.
Nucala is the only biologic approved for COPD that has been evaluated in patients with moderate-to-very-severe airflow limitation, with or without chronic bronchitis, with raised blood eosinophils.
“For too long, the approach to respiratory care has been one-size-fits-all,” said Henry Roberts, managing director of COPD Canada, in a press release. “The development of personalized treatments, like biologics, gives us hope that patients can finally receive care tailored to their unique needs.”
