The EC's decision opens up the monthly biologic for use by COPD patients with an eosinophils phenotype.
The European Commission has approved GSK’s monoclonal antibody Nucala (mepolizumab) for chronic obstructive pulmonary disease (COPD).
The decision makes it the first monthly biologic treatment option in the EU for patients with uncontrolled COPD characterised by raised blood eosinophils.
The interleukin-5 (IL-5)-targeting drug is indicated as an add-on maintenance treatment for these patients who are on inhaled triple therapy.
The approval was based on data from the positive MATINEE phase III trial, which showed that mepolizumab enabled a statistically significant reduction in the annualised rate of moderate or severe exacerbations compared with placebo, both in addition to inhaled triple therapy.
“For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic"
Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: “For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage, hospitalisations and emergency department visits.
“Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD."
The full results from the MATINEE phase III trial were published in The New England Journal of Medicine with further data presented at the 2025 American Thoracic Society International Congress.
Nucala (100mg dose subcutaneous injection) was first approved in 2015 as an add-on maintenance treatment for individuals 12 years old and over with severe eosinophilic asthma. Nucala is also authorised for COPD in the US, UK, and China, and in Europe for four other type 2 inflammation-driven diseases.
In addition to COPD, the biologic was authorised in December 2017 as the first US-approved treatment for the rare autoimmune disease eosinophilic granulomatosis with polyangiitis (EGPA).
Then in September 2019, Nucala became the first US-approved biologic for six- to 11-year-old paediatric patients with severe eosinophilic asthma.
