GSK's COPD treatment approved by FDA

(Sharecast News) - Pharma group GSK has announced that US regulators have approved for use its Nucala treatment for adults with chronic obstructive pulmonary disease (COPD) following positive results from phase III trials. The US Food and Drug Administration has given the green light to Nucala, otherwise known as mepolizumab, as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype, GSK said.

The approval was based on the positive MATINEE and METREX phase III trials, which 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 an important part of managing COPD, as they can cause irreversible lung damage, worsening of symptoms and increased mortality.

Nucala is now the only approved biologic evaluated in patients with an eosinophilic phenotype characterised by a blood eosinophil count threshold as low as ≥150 cells/microliter, and provides hope for COPD sufferers, according to Jean Wright, the head of the COPD Foundation.

"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," Wright said.