Breztri Aerosphere Approved by US FDA for Maintenance Treatment of Asthma in Patients Aged 12 Years and Older

　　On April 28,2026,AstraZeneca announced that its fixed-dose triple combination inhaler therapy Breztri Aerosphere(budesonide/glycopyrrolate/formoterol fumarate)has been officially approved by the U.S.Food and Drug Administration(FDA)for the maintenance treatment of asthma in adult and pediatric patients aged 12 years and older.This marks the first and only single-inhaler triple therapy approved for this population in the United States,representing a significant milestone in asthma treatment.

　　Breztri Aerosphere delivers three active ingredients through the innovative Aerosphere pressurized metered-dose inhaler:inhaled corticosteroid(ICS)budesonide,long-acting beta₂-agonist(LABA)formoterol fumarate,and long-acting muscarinic antagonist(LAMA)glycopyrrolate.The therapy was previously approved in the United States in 2020 for the maintenance treatment of adults with chronic obstructive pulmonary disease(COPD),with more than 6.8 million patients prescribed globally in 2025,making it the fastest-growing fixed-dose triple combination therapy in the COPD field.

　　Approval Basis:Phase III KALOS and LOGOS Clinical Trials

　　This FDA approval is based on efficacy and safety data from two large,replicate confirmatory Phase III clinical trials,KALOS and LOGOS,the results of which were published in The Lancet Respiratory Medicine in February 2026.The trials enrolled approximately 4,300 randomized patients across a broad asthma population,including both patients with and without recent asthma exacerbations.

　　The primary endpoints of the studies were the change from baseline in forced expiratory volume in one second(FEV₁)area under the curve from 0 to 3 hours at week 24,and trough FEV₁at weeks 12-24 and week 24.The results showed that Breztri Aerosphere demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual inhaled ICS/LABA therapy.In a key secondary endpoint,the therapy also exhibited a rapid onset of action,with significant improvements in lung function observed within five minutes after the first dose.

　　In terms of safety,no new safety or tolerability signals were identified for Breztri Aerosphere in either trial.It is important to emphasize that Breztri Aerosphere is a maintenance therapy and is not indicated for the relief of acute bronchospasm or as a rescue inhaler.

　　Addressing Unmet Clinical Needs

　　Asthma is one of the most common chronic respiratory diseases worldwide,affecting up to 262 million people globally,including approximately 27 million people in the United States.Despite the widespread availability of existing dual maintenance therapies,approximately half of all patients still do not achieve adequate disease control,continuing to experience wheezing,dyspnea,chest tightness,and cough caused by airway inflammation and muscle constriction,and may even suffer life-threatening exacerbations.According to statistics,nearly 10 million asthma exacerbations occur annually in the United States.

　　Dr.Njira Lugogo,Clinical Professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan Medical School,stated:"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.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."

　　Ruud Dobber,Executive Vice President of the BioPharmaceuticals Business Unit at AstraZeneca,said:"As the fastest-growing fixed-dose triple combination therapy in COPD,Breztri is already improving outcomes for patients with COPD,and we are proud to extend its benefits to patients with asthma.The FDA approval of Breztri for asthma demonstrates how our innovative science continues to deliver new solutions for people living with respiratory diseases."

　　Global Application and Regulatory Status

　　Breztri Aerosphere(approved under the brand name Trixeo Aerosphere in the European Union)is currently approved for the treatment of adults with COPD in 90 countries worldwide.Regulatory applications for the asthma indication are currently under review in other major regions including the European Union and Japan,with expected expanded global accessibility in the future.

　　AstraZeneca has over 50 years of history in respiratory care and is a globally recognized leader.The company is committed to addressing the significant unmet needs of patients with chronic respiratory diseases through a portfolio of inhaled medicines,biologics,and new modalities,aiming to deliver life-changing medicines that help eliminate COPD as a major cause of death,eliminate asthma attacks,and achieve clinical remission in immune-mediated diseases.