The MHRA has authorised GSK’s Nucala (mepolizumab) in the UK as an add‑on maintenance treatment for adults with uncontrolled COPD of an eosinophilic phenotype who are already receiving triple therapy with an inhaled corticosteroid, a long acting beta2‑agonist and a long‑acting muscarinic antagonist.
The decision follows results from two placebo‑controlled phase 3 studies, MATINEE and METREX, which demonstrated that mepolizumab significantly reduced the annualised rate of moderate or severe exacerbations and extended the time to first exacerbation once treatment had begun. The safety profile was consistent with what is already known for the medicine.
Professor Mona Bafadhel, Director of King’s Centre for Lung Health and Chair of Respiratory Medicine at King’s College London, said: “For people living with COPD, managing exacerbations is an ongoing challenge that significantly impacts their lives, with almost a quarter of hospitalised patients being re-admitted within 30 days. The approval of mepolizumab provides us with a new treatment option that can help people with eosinophilic COPD by reducing the frequency of their exacerbations.”
Dr Joanne Hunt, Medical Head, Specialty, GSK UK, said: “At GSK, we’re committed to redefining respiratory care through innovation. If recommended by the National Institute for Health and Care Excellence (NICE), mepolizumab will be administered every 4 weeks to significantly reduce the rate of moderate/severe exacerbations and delay the time to first moderate/severe exacerbation once commenced on treatment.”
COPD affects an estimated three million people in the UK and is a major driver of emergency hospital admissions. Exacerbations account for a substantial proportion of the condition’s clinical and economic burden, with hospital admissions costing the NHS thousands of pounds per patient.
In both phase 3 trials, mepolizumab added to triple therapy achieved statistically significant reductions in exacerbation rates compared with placebo and prolonged the median time to first moderate or severe exacerbation. NICE and the Scottish Medicines Consortium will now assess the treatment for reimbursement.
