AstraZeneca has won US approval for Breztri Aerosphere as a maintenance treatment for asthma in adults and adolescents aged 12 and over.
The FDA decision was based on the Phase III KALOS and LOGOS trials, which randomised about 4,300 patients and showed statistically significant and clinically meaningful improvements in lung function versus inhaled ICS/LABA, including a rapid onset within five minutes after the first dose, with no new safety or tolerability signals, AstraZeneca said.
"The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner," said Njira Lugogo, MD, Clinical Professor, Division of Pulmonary and Critical Care Medicine, University of Michigan.
Breztri was first approved in the US for COPD in 2020 and was prescribed to more than 6.8 million patients globally in 2025, and the medicine is already approved for COPD in about 90 countries.
KALOS and LOGOS used FEV1 AUC0‑3 at week 24 and trough FEV1 as key endpoints, results were published in The Lancet Respiratory Medicine in February 2026, and regulatory filings for an asthma indication are under review in the EU, Japan and China.
