AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere has been approved in the European Union (EU) as a maintenance treatment for asthma in patients 12 years of age and older.
The approval is for patients who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).
Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan, is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist (LAMA).
Asthma is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide, including nearly 43 million people in Europe. Around half of patients continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway 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.
The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and was based on the positive results from the KALOS and LOGOS phase 3 trials.
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “This 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.”
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. Trixeo is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.
Trixeo/Breztri, is also approved in the US and Japan for treatment of asthma and is currently under review in China, as well as other countries. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan.