AstraZeneca’s Trixeo Aerosphere has been recommended for approval in the European Union as a maintenance treatment for asthma in patients aged 12 years and older who are not adequately controlled on medium-dose inhaled corticosteroid and long-acting beta2-agonist therapy.

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency is based on results from the KALOS and LOGOS Phase 3 trials, which showed statistically significant improvements in lung function compared with inhaled corticosteroid and long-acting beta2-agonist combinations.

A pooled analysis of the two trials also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations with Trixeo compared with the combined inhaled corticosteroid and long-acting beta2-agonist comparators.

If approved by the European Commission, the decision would give Trixeo a second indication in Europe, where it is already approved as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

Trixeo is a fixed-dose triple combination of budesonide, glycopyrronium and formoterol fumarate delivered through a single inhaler. The product is marketed as Breztri Aerosphere in the US, China and Japan.

Phase 3 trials support asthma application

The CHMP recommendation was supported by data from the KALOS and LOGOS Phase 3 trials, which evaluated Trixeo in people with asthma who remained inadequately controlled despite treatment with inhaled corticosteroid and long-acting beta2-agonist therapy.

In the trials, Trixeo demonstrated statistically significant improvements in lung function compared with the combined inhaled corticosteroid and long-acting beta2-agonist comparators.

The pooled analysis also found a reduction in the annualised rate of severe asthma exacerbations in patients receiving Trixeo.

The analysis included a broad population of patients, including those 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, said: “Across Europe, millions of people with asthma still experience reduced lung function, breathing difficulties, exacerbations and significant disruption to daily life due to uncontrolled disease.”

Papi added: “The CHMP positive opinion for Trixeo represents an important step forward, offering a potential new treatment option that could help reduce exacerbations and improve disease control for patients living with asthma independent of their prior exacerbation history.”

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

Triple therapy targets uncontrolled asthma

Trixeo combines three medicines with different mechanisms of action in a single inhaler.

Budesonide is an inhaled corticosteroid that reduces airway inflammation, while glycopyrronium is a long-acting muscarinic antagonist and formoterol fumarate is a long-acting beta2-agonist.

The combination is intended as a maintenance treatment for patients whose asthma remains uncontrolled despite treatment with an inhaled corticosteroid and long-acting beta2-agonist.

The trials also showed a significant improvement in lung function from baseline within five minutes of the first dose, supporting a rapid onset of action.

However, Trixeo is a maintenance treatment and is not intended to relieve sudden breathing problems or replace a rescue inhaler.

No new safety or tolerability signals were identified in the KALOS and LOGOS trials, according to AstraZeneca.

The proposed European asthma indication would apply to patients aged 12 years and older who are not adequately controlled with a combination of a medium-dose inhaled corticosteroid and long-acting beta2-agonist.

AstraZeneca expands respiratory portfolio

The CHMP recommendation follows the approval of Breztri/Trixeo for asthma in the US and adds to the product’s existing use in COPD.

Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease.”

The European recommendation comes as AstraZeneca continues to expand the use of its respiratory medicines across asthma and COPD.

Trixeo/Breztri is already approved for the treatment of COPD in adults in 90 countries worldwide, including the US, European Union, China and Japan.

Regulatory filings for the asthma indication are also under review in other major markets, including Japan and China.

Asthma affects nearly 43 million people in Europe, according to figures provided by AstraZeneca, with around four million new diagnoses each year.

For patients whose asthma remains uncontrolled on dual therapy, persistent symptoms and exacerbations can have a significant impact on quality of life and may increase the risk of serious disease outcomes.

The positive CHMP opinion now moves Trixeo closer to potentially becoming available for asthma maintenance treatment in Europe, subject to a final decision by the European Commission.

The recommendation also strengthens the position of Trixeo as a triple-combination respiratory therapy with applications across both asthma and COPD.