AstraZeneca’s Trixeo Gains EU Approval as Asthma Maintenance Therapy

AstraZeneca (AZN ) announced on 23 September 2026 that the European Commission has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate, BGF 320/28.8/10μg) as a maintenance treatment for asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). The company stated that Trixeo is the first and only triple-combination therapy approved in the European Union for patients 12 years and older, independent of exacerbation history.

Marketed as Breztri Aerosphere in the US, China and Japan, Trixeo Aerosphere is a single inhaler that combines the efficacy of an ICS/LABA pairing with a long-acting muscarinic antagonist (LAMA). The product is a fixed-dose triple combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, and budesonide, an ICS, delivered via the Aerosphere pressurised metered-dose inhaler. AstraZeneca describes Trixeo as a maintenance therapy that is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

The Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). AstraZeneca announced that recommendation on 24 July 2026, stating at the time that an approval would add a second indication for Trixeo in Europe beyond chronic obstructive pulmonary disease (COPD).

KALOS and LOGOS Phase III Programme

The approval was based on positive results from the KALOS and LOGOS Phase III trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators, according to the company. In the pooled analysis of the two trials, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients, including those with no asthma exacerbations in the previous year. In a key secondary endpoint, Trixeo demonstrated a rapid onset of action, with a significant improvement from baseline in lung function within five minutes after the first dose. AstraZeneca reported that no new safety or tolerability signals were identified for Trixeo in the trials. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.

KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel-group, multi-centre, 24-to-52-week variable-length trials designed to assess the efficacy and safety of Breztri/Trixeo Aerosphere against two fixed-dose dual-combination therapies pairing budesonide with formoterol fumarate: Symbicort pressurised metered-dose inhaler and PT009 in an Aerosphere formulation. The two trials included approximately 4,300 randomised 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, and the key secondary endpoint was change from baseline in FEV1 AUC0-3 over 24 weeks, in each case versus the combined ICS/LABA treatment groups. The pooled primary endpoint, prioritised in the testing procedure, was the rate of severe asthma exacerbations versus the combined dual-therapy groups. The primary and secondary endpoints and treatment comparisons in the trials differed according to regulatory submission approaches.

Asthma Burden and Global Regulatory Status

Nearly 43 million people are living with asthma in Europe, and about four million more are newly diagnosed each year, according to figures cited in the company’s announcement. Asthma affects as many as 363 million people worldwide, and around half of patients remain uncontrolled on dual therapies, leading to airway inflammation and bronchoconstriction that cause wheezing, breathlessness, chest tightness, coughing, exacerbations and even death.

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara and primary investigator, said: “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 of AstraZeneca’s BioPharmaceuticals Business Unit, said: “Today’s approval in asthma 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.”

Beyond the EU, Trixeo/Breztri is approved in the US and Japan for the treatment of asthma in patients 12 years of age and older, and the company said the therapy is currently under review in China and other countries, with regulatory filings for asthma under review in all other major regions. Trixeo/Breztri is also approved for the treatment of COPD in adults 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, according to AstraZeneca data on file.