FDA approves Breztri Aerosphere for asthma, introducing the first single-inhaler triple-combination maintenance therapy for patients aged 12 and older.
FDA approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of asthma in adults and adolescents aged 12 and older.
The approval makes it the first and only single-inhaler triple-combination therapy approved for asthma in the United States.1
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Breztri combines three established drug classes in a single inhaler: an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.1 Current standard-of-care dual therapies for asthma combine only the first two classes, so by adding a LAMA component, Breztri addresses an additional pathway of airway narrowing, smooth muscle contraction driven by the muscarinic pathway, that dual therapies do not target.1
The drug is a maintenance therapy and is not intended to replace a rescue inhaler for sudden breathing problems.
Breztri was originally approved in the U.S. in 2020 for the treatment of COPD in adults and has since been prescribed to more than 6.8 million patients globally. The asthma approval represents a significant label expansion into a new and substantially larger indication.
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 people suffering with COPD, and we are proud to extend its benefits to asthma patients. The FDA's approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases."
The approval is based on data from the Phase III Kalos and Logos trials, two replicate confirmatory, randomized, double-blind trials enrolling approximately 4,300 patients with asthma across 24 to 52 weeks.2
The trials evaluated Breztri against dual ICS/LABA therapy in a broad population including patients with and without recent asthma exacerbations. Results were published in The Lancet Respiratory Medicine back in February 2026.
In the trials, Breztri demonstrated a statistically significant and clinically meaningful improvement in lung function compared with dual-combination therapy, measured by forced expiratory volume over one second. In a key secondary endpoint, it also showed a rapid onset of action, with significant improvement in lung function within five minutes of the first dose.2 No new safety or tolerability signals were identified in the trials.
An estimated 27 million people are living with asthma in the U.S., and around half continue to be uncontrolled on dual maintenance therapies. Poorly controlled asthma contributes to nearly 10 million asthma attacks each year, and the ongoing burden of inflammation and airway tightening causes wheezing, breathlessness, chest tightness, and exacerbations that can be life-threatening.1
Njira Lugogo, MD, clinical professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan, said, "Despite the availability of dual maintenance therapy, many patients are still 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."
Regulatory filings for Breztri in asthma are currently under review in the EU, Japan, and China.1
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