HQ Team
May 24, 2025: The Food and Drug Administration has cleared GSK Plc’s drug for treating patients with inadequately controlled chronic obstructive pulmonary disease (COPD).
COPD is a condition caused by damage to the airways or other parts of the lungs. This leads to inflammation and other problems that block airflow and make it hard to breathe.
It’s often caused by smoking and air pollution, and while not curable, its progression can be slowed and symptoms managed with treatment, according to the World Health Organization.
The FDA approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with COPD and an eosinophilic phenotype.
‘Positive end-stage trial data’
The approval was based on “positive” data from end-stage trials where mepolizumab showed a clinically meaningful and statistically significant reduction in the annualised rate of moderate to severe exacerbations versus placebo.
Preventing exacerbations is a key goal of COPD management. Exacerbations are known to cause irreversible lung damage, worsening of symptoms and increased mortality. The incidence of adverse events was similar between the placebo and mepolizumab groups.
Mepolizumab is the only approved biologic evaluated in patients with an eosinophilic phenotype characterised by a blood eosinophil count threshold as low as 150 cells or more, according to a company statement.
The count is measured 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 worsening of the disease or its symptoms.
Exacerbations
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. This represents over a million people at risk of exacerbations.
“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,” said Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, of GSK.
“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.”
Patients with COPD experience persistent respiratory symptoms such as breathlessness, cough, and sputum along with progressive airflow obstruction due to the chronic inflammation, which impacts their daily life.
Third leading cause of death
COPD affects more than 390 million people globally and is the third leading cause of death.
“COPD isn’t just a disease, it’s a relentless cycle,” said Jean Wright, MD, MBA, Chief Executive Officer of the COPD Foundation.
“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,” he said.
Mepolizumab is currently not approved for use in COPD in any other country. Regulatory submissions are under review in China and Europe, according to the statement.
