Biopharmaceutical company AstraZeneca (LSE: AZN) (STO: AZN) (NYSE: AZN) declared on Wednesday that it has received European Commission approval for Trixeo Aerosphere as a maintenance treatment for asthma in patients aged 12 and over who are inadequately controlled on medium-dose inhaled corticosteroid and long-acting beta2-agonist therapy. Trixeo is the first triple-combination therapy approved in the EU for this population regardless of exacerbation history.

This approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and was supported by Phase III KALOS and LOGOS trials. Trixeo demonstrated statistically significant improvements in lung function and, in pooled analysis, a significant reduction in the annualised rate of severe asthma exacerbations versus dual therapy.

The trials involved approximately 4,300 patients and identified no new safety or tolerability signals. Trixeo is marketed as Breztri Aerosphere in the US, China and Japan and is also approved for asthma in the US and Japan, while regulatory reviews are ongoing in other markets.

Trixeo Aerosphere is also approved for chronic obstructive pulmonary disease in more than 90 countries and was prescribed to more than 6.8 million patients globally in 2025.