AstraZeneca obtains FDA green light for Breztri Aerosphere

Patients with chronic obstructive pulmonary disease, or COPD, will soon have a new treatment.

The Food and Drug Administration has cleared AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of COPD.

“Preventing exacerbations is central to the management of a 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,” said Fernando Martinez, chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, 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. COPD is a debilitating progressive condition and the fourth leading cause of death in the United States. We look forward to discussing all-cause mortality data from the Breztri Aerosphere ETHOS trial with health authorities,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D.