AstraZeneca has bagged a green light in the US for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), the third leading cause of death globally.
The approval was based on data from the Phase III ETHOS trial, in which Breztri Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations versus dual-combination therapies Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
Clearance was also supported by efficacy and safety data from the Phase III KRONOS trial, the firm noted.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death. Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD,” commented Fernando J. Martinez, chief of Division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, US, and Investigator in the ETHOS trial.
“Breztri Aerosphere has demonstrated a strong clinical profile compared with dual-combination therapies and offers a meaningful new treatment option for patients,” added Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
Breztri Aerosphere is under regulatory review in the EU.