July 24, 2020: AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
The approval by the US Food and Drug Administration (FDA) was based on positive results 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 compared with dual-combination therapies Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.
Dr. Fernando J. Martinez, Chief of Division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, New York, US and Investigator in the ETHOS trial, said: “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.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Breztri Aerosphere has demonstrated a strong clinical profile compared with dual-combination therapies and offers a meaningful new treatment option for patients.
Chronic obstructive pulmonary disease is a debilitating progressive condition and the fourth leading cause of death in the US. We look forward to discussing all-cause mortality data from the Breztri Aerosphere ETHOS trial with health authorities.”
Results from the Phase III ETHOS trial were published in The New England Journal of Medicine in June 2020 and results from the Phase III KRONOS trial were published in The Lancet Respiratory Medicine in September 2018.
In both trials, the safety and tolerability of Breztri Aerosphere were consistent with the profiles of the dual comparators.
Breztri Aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma in the US or other countries. Breztri Aerosphere is approved in Japan and China for patients with COPD and under regulatory review in the EU.