WILMINGTON, DE — AstraZeneca said the U.S. Food and Drug Administration approved BREZTRI Aerosphere for the maintenance treatment of asthma in patients aged 12 and older, expanding the drug’s use beyond chronic obstructive pulmonary disease.
The approval allows the fixed-dose triple-combination inhaler to be used as a maintenance therapy for asthma in adult and pediatric patients and marks the second FDA-approved indication for the drug. BREZTRI Aerosphere was previously approved in the United States in 2020 for adults with COPD.
According to AstraZeneca, the approval was based on results from the Phase III KALOS and LOGOS clinical trials, which evaluated the therapy in asthma patients with and without recent exacerbations.
The company said the studies showed statistically significant improvements in lung function compared with dual-combination inhaled corticosteroid and long-acting beta2-agonist therapies. In a secondary endpoint, the trials also demonstrated improved lung function within five minutes after the first dose.
BREZTRI Aerosphere combines an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist in a single inhaler. The medication is intended for maintenance treatment and is not designed to replace rescue inhalers for sudden breathing problems.
Njira Lugogo, clinical professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan, said many asthma patients continue to experience uncontrolled symptoms despite existing dual therapies.
“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,” Lugogo said.
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said the company is extending the therapy’s use following its growth in the COPD market.
The company said about 27 million people in the United States live with asthma, with nearly half remaining uncontrolled on dual therapies. AstraZeneca added that nearly 10 million asthma attacks occur annually in the U.S.
Results from the KALOS and LOGOS trials were published in The Lancet Respiratory Medicine in February 2026. AstraZeneca said no new safety or tolerability concerns were identified during the studies.
BREZTRI Aerosphere is approved for COPD treatment in about 90 countries, including the United States, European Union, China, and Japan. Regulatory reviews for asthma indications remain ongoing in several international markets, the company said.
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