The approval are based on a pair of recent phase 3 trials showing the safety and efficacy of budesonide/glycopyrrolate/formoterol fumarate.
The US Food and Drug Administration (FDA) has approved budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere), a triple maintenance therapy for patients with chronic obstructive pulmonary disease (COPD).
The approval, awarded to AstraZeneca, is based on positive results from the phase 3 ETHOS trial, where the treatment showed a statistically significant reduction in the rate of moderate or severe exacerbations compared to dual-combination therapies glycopyrrolate/formoterol fumarate and PT009 (budesonide/formoterol fumarate).
The approval is also based on efficacy and safety data from the phase 3 KRONOS trial.
In both trials the safety and tolerability of the study drug was consistent with the profiles of their dual comparisons.
The ETHOS findings, which were presently virtually at the American Thoracic Society (ATS) 2020 Virtual Sessions, featured 8000-plus patients treated with either dual- or triple-therapy inhaler for their COPD.
Investigators observed annual moderate or severe exacerbation rates of 1.08 and 1.07 in patients treated with 320 mcg and 160 mcg, respectively.
A lower mortality rate was observed in patients with COPD treated with 320 mcg of the triple combination therapy versus those treated with dual therapy.
“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,” Fernando J. Martinez, MD, MS, Chief of Division of Pulmonary and Critical Care Medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, said in a statement.
The triple combination therapy is not currently indicated for the relief of acute bronchospasm or for the treatment of asthma.