Trixeo approved in the EU as first triple combination maintenance therapy for asthma in patients aged 12 and older

AstraZeneca’s Trixeo Aerosphere has been approved in the European Union as a maintenance treatment for asthma in patients aged 12 years and older whose disease is not adequately controlled with a medium dose inhaled corticosteroid combined with a long acting beta2 agonist.

Trixeo Aerosphere is a fixed dose combination of budesonide, glycopyrronium and formoterol fumarate dihydrate.

The single inhaler combines an inhaled corticosteroid and long acting beta2 agonist with a long acting muscarinic antagonist, creating a triple combination maintenance therapy.

AstraZeneca said Trixeo is the first and only triple combination treatment approved in the EU for asthma patients aged 12 and older regardless of their previous exacerbation history.

The European Commission approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The decision was supported by findings from the Phase III KALOS and LOGOS trials.

Across the studies, Trixeo produced statistically significant improvements in lung function compared with inhaled corticosteroid and long acting beta2 agonist combinations.

A pooled analysis of KALOS and LOGOS also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations compared with dual inhaled therapy.

The benefit was observed across a broad patient population, including people who had not experienced an asthma exacerbation during the previous year.

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara and Director of the Respiratory Unit at S. Anna University Hospital in Italy, said many patients continue to experience uncontrolled asthma despite receiving maintenance treatment.

He said persistent breathing difficulties, declining lung function and the risk of serious exacerbations remain important concerns for these patients.

Papi added that approval of a single inhaler triple combination for patients aged 12 and older provides another treatment option that has demonstrated improved asthma control and reduced exacerbation risk regardless of prior exacerbation history.

Ruud Dobber, Executive Vice President and President of AstraZeneca’s BioPharmaceuticals Business Unit, said the asthma approval expands the role of Trixeo beyond its existing use in chronic obstructive pulmonary disease.

He said the decision allows AstraZeneca to offer single inhaler triple therapy to European patients aged 12 and older whose asthma remains uncontrolled despite dual inhaled treatment.

Trixeo also demonstrated a rapid onset of action in a key secondary endpoint.

Patients experienced a significant improvement from baseline in lung function within five minutes of receiving the first dose.

AstraZeneca said Trixeo is intended for maintenance treatment and should not be used to relieve sudden breathing problems or replace a rescue inhaler.

The KALOS and LOGOS findings were published in The Lancet Respiratory Medicine in February 2026.

No new safety or tolerability concerns were identified in either Phase III study.

Nearly 43 million people in Europe are living with asthma, with around four million additional people diagnosed each year.

Patients whose disease is not adequately controlled on dual therapy can continue to experience symptoms including wheezing, shortness of breath and coughing, as well as potentially serious exacerbations.

Trixeo is marketed as Breztri Aerosphere in the U.S., China and Japan.

The medicine is also approved for asthma in the U.S. and Japan and remains under regulatory review in China and other markets.

Trixeo and Breztri are additionally approved for the treatment of chronic obstructive pulmonary disease in adults in around 90 countries, including the U.S., EU, China and Japan.

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