GSK announced that the European Medicines Agency (EMA) has accepted its application to expand the use of Nucala (mepolizumab) for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
The British drugmaker’s application is supported by data from the Phase 3 MATINEE trial, in 804 patients with diverse COPD phenotypes, including elevated blood eosinophil counts.
The randomised, double-blind study assessed the efficacy and safety of Nucala 100mg as an add-on therapy, administered subcutaneously every four weeks.
In the Phase 3 study, Nucala showed a statistically significant and clinically meaningful reduction in the annualised rate of exacerbations compared to a placebo.
Nucala is a monoclonal antibody targeting interleukin-5 (IL-5), a cytokine involved in type 2 inflammation, which is a contributing factor in many diseases, including COPD.
The MATINEE trial showed that adding Nucala to inhaled maintenance therapy significantly reduced exacerbation rates over a period of 52 to 104 weeks, which is the primary endpoint.
Nucala is approved in Europe for four IL-5 mediated conditions, including severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps, among others.
Currently, the drug is not approved for COPD treatment in any country, but it would become the first biologic with monthly dosing for COPD patients if approved.
Nucala’s development programme in COPD includes three clinical trials, METREX, METREO and MATINEE, of which the first two studies were completed in 2017.
MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies to identify the patients who could benefit the most.
GSK, in its statement, said: “COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema.
“Type 2 inflammation is present in a variety of immuno-inflammatory conditions and is a major contributor to symptoms and exacerbations in up to 40% of people with COPD.
“There is evidence to show IL-5 has broad effects on other structural and immune and cell types beyond eosinophils, and how they contribute to inflammation, which can lead to lung remodelling and disease progression.”
Last month, China’s National Medical Products Administration (NMPA) accepted GSK’s new drug application for the use of Nucala to treat COPD with an eosinophilic phenotype.
