AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the EU for maintenance treatment in adults with moderate to severe chronic obstructive pulmonary disease (COPD).

Specifically, doctors can prescribe the drug for patients who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).

The approval rides on data from the ETHOS Phase III trial, in which Trixeo Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks.

The application also contained efficacy and safety data from the KRONOS Phase III trial.

COPD is a progressive disease that can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It is the third leading cause of death globally.

COPD “significantly contributes to morbidity and healthcare resource utilisation in Europe. Even a single exacerbation can cause further deterioration of a patient’s lung function and increase the risk of hospitalisation, so preventing exacerbations is a clinical priority,” noted Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and lead investigator of the ETHOS Phase III trial.

“Trixeo Aerosphere has demonstrated significant benefits in reducing exacerbations in patients with moderate to severe disease, and triple-combination therapy will play an increasingly important clinical role in treating these patients.”

“Trixeo Aerosphere has a strong clinical profile compared with dual-combination therapies and offers an important new treatment option for patients with chronic obstructive pulmonary disease,” added Mene Pangalos, executive vice president, BioPharmaceuticals R&D, at AZ.

“In Europe, about one in 10 adults over the age of 40 has chronic obstructive pulmonary disease, with prevalence increasing. We look forward to discussing all-cause mortality data from the ETHOS Phase III trial with health authorities.”