- Health Canada has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with COPD and elevated blood eosinophils whose disease remains uncontrolled despite triple therapy with ICS/LABA/LAMA.
- The approval is supported by results from the Phase III MATINEE, METREX, and METREO trials, where Nucala reduced the rate of moderate-to-severe COPD exacerbations compared with placebo.
- In the MATINEE study, Nucala also showed a numerical reduction in exacerbations requiring hospitalization or emergency department visits, addressing a major burden in COPD care.
- Nucala becomes the only approved biologic in COPD with efficacy data spanning up to two years across a broad eosinophilic COPD population, offering a more personalized treatment option for patients at risk of recurrent flare-ups.
Takeaways:
Health Canada’s decision makes Nucala the first biologic add‑on for eosinophilic COPD in Canada, opening a new high-value segment on top of triple inhaled therapy for patients with frequent exacerbations. This should drive uptake in a biomarker-defined subgroup with raised blood eosinophils, reduce moderate-to-severe flare-ups and potentially hospitalizations, and strengthen GSK’s respiratory biologics franchise
Source: CA Newswire
