FDA Approves Breztri Aerosphere as First Triple-Therapy Inhaler for Asthma
FDA approves AstraZeneca's Breztri Aerosphere as the first single-inhaler triple therapy for asthma in patients aged 12+, based on Phase III KALOS and LOGOS trials showing improved lung function and reduced exacerbations versus dual therapy.
The FDA has approved AstraZeneca's Breztri Aerosphere for maintenance treatment of asthma in adults and adolescents aged 12 and older, making it the first single-inhaler triple therapy authorised for the condition in the US. The approval, announced on April 28, 2026, adds a second indication to Breztri beyond its existing COPD licence, which was first cleared in 2020.
Breztri combines budesonide (an inhaled corticosteroid, ICS), glycopyrrolate (a long-acting muscarinic antagonist, LAMA), and formoterol fumarate (a long-acting beta2-agonist, LABA), delivered via the Aerosphere pressurized metered-dose inhaler. The platform required solving particle engineering and suspension stability challenges to co-formulate three active substances with distinct physicochemical properties.
The approval was based on efficacy and safety data from the Phase III KALOS and LOGOS trials, replicate confirmatory, randomized, double-blind, double-dummy, parallel group, multi-center studies enrolling approximately 4,300 randomized patients across 24-to-52-week variable-length treatment periods. Results were published in The Lancet Respiratory Medicine in February 2026. The trials compared Breztri against dual-combination ICS/LABA therapy, including both a marketed reference product (Symbicort) and a formulation-matched comparator (budesonide/formoterol fumarate in the same Aerosphere device), allowing regulators to isolate the contribution of the added LAMA component.
Across both trials, Breztri demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual ICS/LABA therapy. Results showed improvements of 76 mL and 90 mL in lung function as measured by forced expiratory volume in 1 second (FEV1) and the FEV1 area under the curve from 0 to 3 hours at week 24, respectively. A key secondary endpoint also showed a significant improvement from baseline in lung function within five minutes of the first dose. Significant reductions in the yearly rate of severe asthma exacerbations were also reported. No new safety or tolerability signals were identified relative to the established COPD profile.
Primary endpoints were also met in the supporting LITHOS and VATHOS trials, which included approximately 1,000 randomized patients.
The approval addresses a substantial unmet need. Asthma affects an estimated 262 million people worldwide, including 27 million in the US. Approximately half of those patients remain inadequately controlled on dual therapy. 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.
Breztri is currently approved for COPD in 90 countries and was prescribed to more than 6.8 million patients globally in 2025. Regulatory submissions for the asthma indication are under review in the EU, Japan, and China.