AstraZeneca (LSE:AZN) has taken another step towards expanding the use of its Trixeo Aerosphere inhaler after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending its approval for asthma treatment across the European Union.
The recommendation applies to patients aged 12 years and older whose asthma remains inadequately controlled despite treatment with a medium-dose inhaled corticosteroid and a long-acting beta2-agonist.
Triple-therapy inhaler targets uncontrolled asthma
Trixeo Aerosphere combines three established therapies into a single inhaler, including an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist.
If approved by the European Commission, the treatment would offer an additional maintenance therapy option for patients whose symptoms are not sufficiently managed with dual therapy.
Phase III studies support recommendation
The CHMP’s positive opinion was supported by data from the Phase III KALOS and LOGOS clinical trials.
Both studies demonstrated statistically significant improvements in lung function compared with dual-therapy treatments.
A pooled analysis of the trial results also found that Trixeo reduced the annualised rate of severe asthma exacerbations across a broad group of patients, including individuals with no previous history of severe exacerbations.
Rapid improvement in lung function observed
The treatment also achieved one of its key secondary objectives by delivering measurable improvements in lung function within five minutes of the first administered dose.
Researchers reported no new safety or tolerability concerns during the clinical programme.
Findings from the KALOS and LOGOS trials were published in The Lancet Respiratory Medicine in February 2026.
Global regulatory expansion continues
Outside Europe, the medicine is marketed as Breztri Aerosphere in the United States, China and Japan.
It is already approved in the United States for the maintenance treatment of asthma, while regulatory applications remain under review in both Japan and China.
Trixeo/Breztri has also received approval for the treatment of chronic obstructive pulmonary disease (COPD) in adults across approximately 90 countries, including the United States, the European Union, China and Japan.
Asthma remains a major health challenge across Europe
According to AstraZeneca, nearly 43 million people across Europe are living with asthma, with around four million new cases diagnosed each year.
A positive opinion from the CHMP is an important milestone in the European approval process, with the final decision now resting with the European Commission.
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