AstraZeneca's Breztri Aerosphere Receives US Approval for COPD Maintenance Treatment
The US Food and Drug Administration (FDA) has approved AstraZeneca's Breztri Aerosphere for the maintenance treatment of patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has received approval from the US Food and Drug Administration (FDA) for use as a maintenance treatment in patients with Chronic Obstructive Pulmonary Disease (COPD).
The approval was based on Phase III clinical trial data. The ETHOS trial demonstrated that Breztri Aerosphere, a triple-combination therapy, significantly reduced the rate of moderate or severe exacerbations compared to dual-combination therapies. Efficacy and safety data from the KRONOS trial also supported the FDA's decision.
"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 can increase the risk of death," stated Dr. Fernando J. Martinez, Chief of Division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine. "Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD."
Breztri Aerosphere is indicated for the maintenance treatment of COPD, not for acute bronchospasm or asthma. AstraZeneca is also preparing to discuss all-cause mortality data from the ETHOS trial with regulatory authorities. COPD affects an estimated 384 million people worldwide and is the fourth leading cause of death in the US.