AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) 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 by the European Commission was based on positive results 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 approval was also supported by efficacy and safety data from the KRONOS Phase III trial.

Trixeo Aerosphere was recommended for marketing authorization by the Committee for Medicinal Products for Human Use of the European Medicines Agency in October 2020.

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

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, said: “Chronic obstructive pulmonary disease significantly contributes to morbidity and healthcare resource utilization in Europe. Even a single exacerbation can cause further deterioration of a patient’s lung function and increase the risk of hospitalization, so preventing exacerbations is a clinical priority. 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.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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. 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.”

Results from the ETHOS Phase III trial were published in The New England Journal of Medicine in June 2020 and results from the KRONOS Phase III trial were published in The Lancet Respiratory Medicine in September 2018. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators.