Global biopharma company, GSK plc., 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.

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.

Mepolizumab is the only approved biologic evaluated in patients with an eosinophilic phenotype characterised by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL. BEC is captured by a simple blood test that measures levels of eosinophils, a type of white blood cell that is a biomarker for type 2 inflammation and indicates a patient’s risk of exacerbation. Approximately 70 percent of COPD patients in the US who are inadequately controlled on inhaled triple therapy and continue to exacerbate have a BEC starting at 150 cells/μL and above. This represents over a million people at risk of exacerbations, including those leading to emergency department (ED) visits and/or hospitalisations, who could add mepolizumab as an option to their COPD treatment.  

 “The approval of Nucala in the US provides an important option for COPD patients. Long-term follow-up studies have demonstrated that exacerbations are the single most important predictor of future risk, with particularly poor outcomes in those requiring hospital visits or admissions. Today, there is hope for improved care for COPD patients with an eosinophilic phenotype, including those with a BEC threshold as low as ≥150cells/μL who need new options like Nucala to support their treatment journey,” said, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, Kaivan Khavandi. 

 “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,” said, MD, MBA, Chief Executive Officer of the COPD Foundation, Jean Wright. 

Mepolizumab is currently not approved for use in COPD in any other country. Regulatory submissions are under review in China and Europe.