FDA
FDA clears Breztri as first single‑inhaler triple therapy for asthma
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is now FDA‑approved for the maintenance treatment of asthma in adults and adolescents 12 years and older, becoming the first and only fixed‑dose triple‑therapy inhaler for this population. Breztri has been approved in the U.S. for the maintenance treatment of chronic obstructive pulmonary disease in adults since 2020.
Approval for the new indication is based on the phase 3 KALOS and LOGOS trials, two replicate, randomized studies enrolling approximately 4,300 patients with asthma, with or without a recent exacerbation history. Breztri demonstrated statistically significant and clinically meaningful improvements in lung function vs. dual ICS/LABA therapy, with gains observed in FEV₁ area under the curve at week 24 and trough FEV₁ across 12–24 weeks. Notably, a key secondary endpoint showed rapid bronchodilation, with significant lung function improvement within five minutes of the first dose.
Across these trials, no new safety or tolerability signals were identified, consistent with the established profile of the individual components.
“Despite the availability of dual maintenance therapy, many patients remain at risk for exacerbations and experience daily breathing difficulties, reduced lung function, and the ongoing fear of worsening symptoms,” said Njira Lugogo, MD, of the University of Michigan. She added that the approval “marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”
Source: AstraZeneca. (2026, April 28). Press release. Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older