24 July 2026 - Recommendation based on KALOS and LOGOS Phase 3 trials demonstrating statistically significant and clinically meaningful benefits of AstraZeneca’s single-inhaler fixed-dose triple therapy compared with inhaled dual therapy.

AstraZeneca’s fixed dose triple combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate (320/28.8/9.6 μg)) has been recommended for approval in the European Union for the maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and long-acting beta2 agonist.

Read AstraZeneca press release