GSK’s Nucala Receives FDA Approval for COPD Treatment

UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab). The interleukin-5 (IL-5) inhibitor is now authorized for use as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Clinical Trial Results
The FDA’s decision is based on positive results from the Phase III MATINEE and METREX studies. These studies demonstrated that mepolizumab significantly reduced the annualized rate of moderate/severe exacerbations compared to placebo in a wide spectrum of COPD patients with an eosinophilic phenotype. The reduction was both clinically meaningful and statistically significant. Additionally, the incidence of adverse events was similar between the placebo and mepolizumab groups, indicating a favorable safety profile.-Fineline Info & Tech