GSK (GSK) said Thursday that the US Food and Drug Administration has approved the use of monoclonal antibody mepolizumab, Nucala, as an add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease.
The approval follows "positive" results from the company's Matinee and Metrex phase III trials. During the trials, mepolizumab, when used with triple inhaled therapy, showed significant reduction in the annualized rate of moderate and severe exacerbations against placebo in COPD patients with an eosinophilic phenotype, the company said.
GSK said regulatory submissions for mepolizumab's use in COPD are currently under review in China and Europe. It has not been approved for use in COPD in any other country.
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