AstraZeneca’s Breztri Aerosphere becomes first single-inhaler triple therapy approved by FDA for maintenance treatment of asthma in US

AstraZeneca’s fixed-dose triple-combination inhaler Breztri Aerosphere has received US Food and Drug Administration (FDA) approval for the maintenance treatment of asthma in adults and adolescents aged 12 and older — marking the first time a single-inhaler triple therapy has been approved for the condition in the US.

The approval, which adds a second indication to Breztri beyond its existing COPD licence, was based on efficacy and safety data from the Phase III KALOS and LOGOS trials, the results of which were published in The Lancet Respiratory Medicine in February 2026. Across both trials, Breztri — which combines an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) — 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 from baseline in lung function within five minutes of the first dose.

The KALOS and LOGOS trials enrolled approximately 4,300 randomised patients across a broad population, including those with and without a recent asthma exacerbation. No new safety or tolerability signals were identified.

The approval addresses a substantial unmet need. Around 27 million people in the US are living with asthma, and approximately half remain uncontrolled on existing dual therapies. Nearly 10 million asthma attacks occur in the US annually, with uncontrolled disease associated with persistent bronchoconstriction, reduced quality of life, and risk of death.

Regulatory submissions for Breztri in asthma are currently under review in the EU, Japan and China. The therapy is already approved for COPD in 90 countries and was prescribed to more than 6.8 million patients globally in 2025.