GlaxoSmithKline’s (GSK) Nucala (mepolizumab) has been approved by the MHRA to treat adults with uncontrolled chronic obstructive pulmonary disease (COPD).
Around three million people in the UK suffer from COPD, which includes emphysema (damage to the air sacs in the lungs) and chronic bronchitis along with other lung conditions as a result of inflamed or damaged lungs and airways. It’s the second most common cause of emergency hospital admissions and the leading cause of re-admissions in the UK.
Symptoms of COPD include breathlessness, persistent cough and wheezing, and frequent chest infections, with the NHS spending around £2bn each year caring for patients with the disease.
By 2030, healthcare costs are predicted to increase to £2.5bn each year as the number of people living with COPD in England is expectedto rise by projected 40%.
The MHRA’s approval is based on results from the phase 3 MATINEE and METREX trials of Nucala as a COPD treatment. In both trials, treatment with Nucala alongside triple therapy demonstrated statistically significant reduction in the rate of moderate to severe disease exacerbations compared to placebo.
In the MATINEE trial, Nucala showed a 35% reduction compared to placebo in the rate of exacerbations leading to hospitalisation or emergency department visits, although this secondary endpoint was not considered statistically significant.
The safety profile of Nucala in both studies was found to be consistent with the drug’s established safety profile in other indications.
Nucala is a monoclonal antibody designed to target and bind to interleukin-5 (IL-5), thus reducing type 2 inflammation.
Professor Mona Bafadhel, 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.”
NICE is expected to issue a decision on whether it will recommend Nucala to treat COPD later this year.
Dr Joanne Hunt, medical head, speciality at GSK UK, said: “If recommended by NICE, mepolizumab will be administered every four weeks to significantly reduce the rate of moderate/severe exacerbations and delay the time to first moderate/severe exacerbation once commenced on treatment.”