AstraZeneca's Trixeo approved in EU for asthma maintenance treatment

AstraZeneca announced on 23 September 2026 that its fixed-dose triple-combination Trixeo Aerosphere, containing budesonide, glycopyrronium, and formoterol fumarate dihydrate at doses of 320/28.8/10 micrograms, has been approved in the European Union as a maintenance treatment for asthma in patients 12 and older who are not adequately controlled on a medium dose inhaled corticosteroid combined with a long-acting beta2-agonist.¹

The company said Trixeo is the first and only triple-combination therapy approved in the EU for patients 12 years and older, independent of exacerbation history.¹ The same product is sold under the name Breztri Aerosphere in the US, China, and Japan, and it combines an inhaled corticosteroid and long-acting beta agonist with a long-acting muscarinic antagonist.

The EU decision followed a positive opinion from the EMA's CHMP and rested on data from the KALOS and LOGOS Phase III trials.¹ AstraZeneca said Trixeo showed statistically significant improvements in lung function compared with combined ICS/LABA comparators, and in the pooled analysis of the two trials, Trixeo produced a statistically significant drop in the yearly rate of severe asthma exacerbations versus those comparators across a broad group of patients, including those with no exacerbations in the prior year.¹

A secondary endpoint showed a fast onset of action, with measurable lung function improvement within five minutes of the first dose; the company noted Trixeo is intended for maintenance use only and does not replace a rescue inhaler.¹ Results from the two trials were published in The Lancet Respiratory Medicine in February 2026, and the company reported no new safety or tolerability signals in the trials.¹

The trials were described as replicate confirmatory, randomized, double-blind, double-dummy, parallel-group, multi-center studies running 24 to 52 weeks, comparing Trixeo against Symbicort and against PT009 in Aerosphere form, and enrolling about 4,300 patients combined.¹ Trixeo/Breztri is already approved for asthma in the US and Japan and remains under review for asthma in China and other countries,¹ while it is separately approved for COPD in more than 90 countries.