Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD)

GSK plc (LSE/NYSE: GSK) today 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 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 annualized rate of moderate/severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype.^1,2 Preventing exacerbations is a key goal of COPD management.³ Exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms and increased mortality.³ The incidence of adverse events was similar between placebo and mepolizumab groups.^1,2

Mepolizumab is the only approved biologic evaluated in patients with an eosinophilic phenotype characterized by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL.^1,2 BEC is captured by a simple blood test that measures levels of eosinophils, a type of white blood cell which is a biomarker for type 2 inflammation and indicates a patient’s risk of exacerbation.³ Approximately 70% 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.^4,5 This represents over a million people at risk of exacerbations, including those leading to emergency department (ED) visits and/or hospitalizations, who could add mepolizumab as an option to their COPD treatment.^4,5

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “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 ≥150 cells/μL who need new options like Nucala to support their treatment journey.”