AstraZeneca’s Breztri approved in the US for asthma, becoming the first and only single-inhaler triple therapy for patients aged 12 and older

AstraZeneca has secured FDA approval for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as a maintenance treatment for asthma in adult and paediatric patients aged 12 and older, marking the therapy’s second approved indication following its 2020 approval for chronic obstructive pulmonary disease. Breztri combines an inhaled corticosteroid and long-acting beta2-agonist with a long-acting muscarinic antagonist in a single inhaler, and is now the only triple therapy available for asthma in this age group.

The commercial opportunity is substantial. There are 27 million people living with asthma in the US, with around half remaining uncontrolled on existing dual therapies. Breztri was already prescribed to more than 6.8 million patients globally in 2025 for COPD, where it is the fastest growing fixed-dose triple combination therapy, and regulatory filings for the asthma indication are currently under review in the EU, Japan and China.

The approval is based on data from the Phase III KALOS and LOGOS trials, which investigated Breztri across a broad asthma population including patients with and without recent exacerbations. Breztri demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual ICS/LABA therapy. A key secondary endpoint also showed a significant improvement in lung function within five minutes of the first dose, suggesting a rapid onset of action. No new safety or tolerability signals were identified. Results were published in the Lancet Respiratory Medicine in February 2026.

Njira Lugogo, Clinical Professor of Pulmonary and Critical Care Medicine at the University of Michigan, described the approval as a meaningful step forward for patients still struggling on existing regimens: “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 marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”

Ruud Dobber, AstraZeneca’s Executive Vice President for its BioPharmaceuticals Business Unit, pointed to the broader pipeline potential: “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.”

Breztri is approved for COPD in 90 countries worldwide. It is a maintenance therapy and is not intended to relieve acute breathing problems or replace a rescue inhaler.

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