The U.S. Food and Drug Administration has approved Nucala (mepolizumab) as a supplementary treatment for elderly individuals with severe chronic obstructive pulmonary disease (COPD).
Nucala is the only approved biologic, which is assessed in patients whose eosinophilic phenotype is described as a blood eosinophil count (BEC) threshold as less as ≥150 cells/µL.
How Nucala received FDA's approval?
In the USA, 70% of COPD patients whose disease is not poorly controlled with inhaled triple therapy and who experience exacerbations have a BEC ≥150 cells/µL.
Nucala received approval depending on the results of two phase 3, randomized (1:1), double-blind, parallel-group trials, MATINEE and METREX.
Both groups were given up to 100 mg of Nucala administered subcutaneously after every four weeks.
In the MATINEE trial, giving Nucala to triple inhaled therapy in COPD patients with BEC ≥300 cells/µL reduced moderate/severe exacerbations (0.80 vs. 1.01/year; rate ratio 0.79) and ED/hospital visits (rate ratio 0.65).
In the METREX trial, Nucala caused exacerbations (1.40 vs. 1.71/year; rate ratio 0.82).
Jean Wright, M.D., chief executive officer of the COPD Foundation stated:
"COPD isn't just a disease, it's a relentless cycle. For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD."
Reported side effects for both the Nucala and placebo groups were similar.
