Pharmaceutical manufacturer AstraZeneca announced in a press release that the U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Breztri Aerosphere for the maintenance treatment of asthma in adults and pediatric patients aged 12 years and older. This expands the therapy’s use beyond COPD.
The approval makes Breztri the only single‑inhaler, fixed‑dose triple therapy approved for asthma in this age group in the United States. According to AstraZeneca, the FDA’s decision was supported by efficacy and safety data from the phase 3 KALOS and LOGOS trials, which demonstrated statistically significant and clinically meaningful improvements in lung function compared with standard dual‑combination inhaled therapies.
“As the fastest-growing, fixed-dose, triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients,” said Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals business unit, in a press release. “The FDA’s approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”
Breztri combines an inhaled corticosteroid (ICS) and long‑acting beta2‑agonist (LABA) with a long‑acting muscarinic antagonist (LAMA) in a single inhaler. The therapy was first approved in the United States in 2020 for adults with COPD and has since been prescribed to more than 6.8 million patients globally.
In the KALOS and LOGOS trials, which enrolled approximately 4,300 patients with asthma, Breztri showed superior lung function improvements versus dual ICS/LABA therapy. The studies also demonstrated a rapid onset of action, with significant improvements in lung function observed within five minutes of the first dose. No new safety or tolerability concerns were identified during the trials.
Results from both trials were published in The Lancet Respiratory Medicine in February 2026. Although Breztri is approved as a maintenance therapy, it is not indicated for the relief of acute breathing symptoms and does not replace rescue inhalers, AstraZeneca stated.
Breztri is currently approved for COPD treatment in 90 countries worldwide, including the United States, European Union, China and Japan. Regulatory reviews for its use in asthma are ongoing in several major global markets.
