AstraZeneca’s Trixeo approved in EU for asthma
pharmafile | October 8, 2026 | News story | | Asthma & COPD, AstraZeneca, EU
AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate) has been approved in the European Union as a maintenance treatment for asthma in patients aged 12 and older whose disease is not adequately controlled with medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination therapy.
The fixed-dose triple combination adds a long-acting muscarinic antagonist (LAMA) to ICS/LABA in a single inhaler. The European Commission approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from the phase 3 KALOS and LOGOS trials.
Across the trials, Trixeo produced statistically significant improvements in lung function compared with ICS/LABA comparators. A pooled analysis also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations, including among patients who had not experienced an exacerbation in the previous year.
Trixeo demonstrated a significant improvement in lung function within five minutes of the first dose, although it is a maintenance treatment and is not intended to relieve acute breathing difficulties or replace a rescue inhaler.
No new safety or tolerability signals were identified in the trials.
Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, said the approval provided a new option for patients whose asthma remains uncontrolled despite maintenance treatment.
Trixeo is already approved for asthma in the US and Japan, where it is marketed as Breztri Aerosphere, and is under review in China. It is also approved for chronic obstructive pulmonary disease (COPD) in adults in around 90 countries.
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