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Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).
According to a Dec. 14, 2020 press release, Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide)—AstraZeneca’s triple-combination therapy—has been approved for use in the European Union (EU).
Trixeo Aerosphere, which is marketed as Breztri Aerosphere in the United States, China, and Japan, has been approved for the treatment of 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 made by the European Commission has been based on the results of the ETHOS Phase III trial.
“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,” said 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, in the press release. “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, AstraZeneca, added, in the press release, “Trixeo Aerosphere has a strong clinical profile compared with dual-combination therapies and offers an important new treatment option for patients with COPD. In Europe, about one in 10 adults over the age of 40 has COPD, with prevalence increasing. We look forward to discussing all-cause mortality data from the ETHOS Phase III trial with health authorities.”