AstraZeneca's Trixeo Aerosphere Wins EU Approval as First Triple-Combination Asthma Maintenance Therapy for Patients 12 and Older
核心洞察
The European Commission approved Trixeo Aerosphere as maintenance treatment for asthma (搜索) in patients 12 years and older uncontrolled on medium-dose ICS/LABA therapy.
Trixeo becomes the first and only triple-combination therapy approved in the EU for asthma (搜索) regardless of patients' prior exacerbation history.
Approval rests on the Phase III KALOS and LOGOS trials, which showed significant lung function gains and fewer severe exacerbations versus ICS/LABA comparators.
The European Commission has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate, 320/28.8/10 µg) as a maintenance treatment for asthma (搜索) in patients aged 12 years and older whose disease is not adequately controlled with a medium-dose inhaled corticosteroid (搜索) (ICS) and long-acting beta2-agonist (搜索) (LABA) combination. AstraZeneca announced the decision, which makes Trixeo the first and only triple-combination therapy approved in the European Union for this population, independent of exacerbation history.
The approval follows a positive opinion from the European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) and is based on results from the Phase III KALOS and LOGOS trials. Trixeo is marketed as Breztri Aerosphere in the US, China and Japan.
Trial Design and Endpoints
KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel-group, multicentre Phase III trials of 24 to 52 weeks variable length. They assessed the efficacy and safety of Trixeo against two fixed-dose dual-combination therapies containing budesonide (an ICS) and formoterol fumarate (a LABA): Symbicort pressurised metered-dose inhaler and PT009 in an Aerosphere formulation. The two trials randomised approximately 4,300 patients.
In the data package submitted to the EMA, the primary lung function endpoint in the individual trials was change from baseline in morning pre-dose trough FEV1 over 24 weeks, with change from baseline in FEV1 AUC0-3 over 24 weeks as the key secondary endpoint, both versus the combined ICS/LABA treatment groups. The pooled primary endpoint, prioritised in the testing procedure, was the rate of severe asthma (搜索) exacerbations versus the combined dual-therapy groups. AstraZeneca notes that primary and secondary endpoints and treatment comparisons differed between the trials according to regulatory submission approaches.
Efficacy Findings
Trixeo demonstrated statistically significant improvements in lung function compared with the combined ICS/LABA comparators. In the pooled analysis of KALOS and LOGOS, the triple combination produced a statistically significant reduction in the annualised rate of severe asthma (搜索) exacerbations across a broad patient population, including patients who had experienced no asthma exacerbations in the previous year.
On a key secondary endpoint, Trixeo showed a rapid onset of action, with a significant improvement from baseline in lung function within five minutes after the first dose. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.
No new safety or tolerability signals were identified for Trixeo in the trials, and findings were consistent with the known profile of the medicine.
Investigator and Company Comment
Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: "Every day, I see patients whose asthma (搜索) remains uncontrolled despite maintenance treatment, leaving them with persistent symptoms like difficulty breathing and declining lung function and at risk of exacerbations, which can have serious health consequences. The approval of Trixeo in Europe as the first triple-combination therapy in a single inhaler for patients 12 years of age and older provides an important new treatment option that has been shown to improve asthma control and reduce future risk of exacerbations, regardless of exacerbation history."
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: "Today's approval in asthma (搜索) builds on Trixeo's established role in improving outcomes in patients with COPD. This means we can now bring the benefits of a single-inhaler triple-combination therapy to people aged 12 years and older in Europe whose asthma remains uncontrolled on dual inhaled therapy."
Disease Burden and Unmet Need
Asthma (搜索) is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide, including nearly 43 million in Europe, where about four million more people are newly diagnosed each year. Around half of patients remain uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing, exacerbations and even death. Many patients remain uncontrolled despite the availability of standard-of-care medicines and continue to experience significant limitations on lung function and reduced quality of life.
Trixeo is a single-inhaler, fixed-dose triple combination of formoterol fumarate (a LABA), glycopyrronium bromide (a long-acting muscarinic antagonist (搜索)) and budesonide (an ICS), delivered via the Aerosphere pressurised metered-dose inhaler. It is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
Regulatory and Commercial Footprint
Breztri/Trixeo is already approved for asthma (搜索) in patients 12 years of age and older in the US, Europe and Japan, with regulatory filings for the asthma indication under review in all other major regions, including China. The medicine is also approved for the treatment of chronic obstructive pulmonary disease (搜索) in more than 90 countries worldwide, including the US, EU, China and Japan, and was prescribed to more than 6.8 million patients globally in 2025.
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver for the company. AstraZeneca describes a 50-year heritage in respiratory care and a portfolio spanning inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.