LONDON (dpa-AFX) - GSK plc. (GSK, GSK.L) announced that the US Food and Drug Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
The FDA's approval was based on data from the positive MATINEE and METREX phase III trials. Across the trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype.
Mepolizumab is currently not approved for use in chronic obstructive pulmonary disease in any other country. Regulatory submissions are under review in China and Europe.
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