The FDA has approved anti–interleukin-5 (IL-5) monoclonal antibody mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease and an eosinophilic phenotype, the company announced.
The expanded indication allows Nucala—already approved for several eosinophil-driven conditions—to be used in patients with chronic obstructive pulmonary disease (COPD) who are inadequately controlled on inhaled maintenance therapy and have a blood eosinophil count (BEC) of at least 150 cells/µL.
Mepolizumab is the only FDA-approved biologic studied in a broad COPD population with an eosinophilic phenotype defined by BEC as low as 150 cells/µL. Approximately 70% of patients in the U.S. who remain inadequately controlled on inhaled triple therapy have a BEC of at least 150 cells/µL.
Approval was supported by findings from two phase III trials—MATINEE and METREX—in which mepolizumab added to standard inhaled triple therapy demonstrated statistically significant reductions in moderate or severe exacerbations compared with placebo. In the MATINEE trial, patients experienced a 21% reduction in moderate or severe exacerbations when treated for up to 104 weeks. Similarly, the METREX trial reported a rate ratio of 0.82.
In a predefined secondary endpoint in MATINEE, the annualized rate of exacerbations requiring emergency department visits or hospitalizations was lower in the mepolizumab group; however, this finding was not statistically significant due to hierarchical testing procedures.
Mepolizumab binds to IL-5, a cytokine involved in the development and survival of eosinophils, thereby reducing eosinophil counts and associated airway inflammation.
Other FDA-approved therapies for eosinophilic COPD include dupilumab (Dupixent) and ensifentrine (Ohtuvayre), an inhaled dual inhibitor of phosphodiesterase 3 and 4.
There is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150 cells/μL who need new options like Nucala to support their treatment journey, said Kaivan Khavandi, senior vice president, Global Head, Respiratory, Immunology & Inflammation R&D, GSK.
Source: GSK Press Release