Nucala approved by FDA for use in adults with COPD

UK pharma major GSK (LSE: GSK) yesterday announced that the US Food and Drug Administration (FDA) 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 these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype.

Preventing exacerbations is a key goal of COPD management. Exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms and increased mortality. The incidence of adverse events was similar between placebo and mepolizumab groups.