AstraZeneca (NASDAQ: AZN) announced that the European Commission has approved its fixed-dose triple-combination inhaler Trixeo Aerosphere 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 and long-acting beta2-agonist.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. It was based on results from the Phase III KALOS and LOGOS trials, which showed statistically significant improvements in lung function compared with combined dual-therapy comparators. A pooled analysis of the two trials also showed a statistically significant reduction in the annualized rate of severe asthma exacerbations versus dual-therapy comparators.

Trixeo, marketed as Breztri Aerosphere in the US, China, and Japan, combines an inhaled corticosteroid and long-acting beta2-agonist with a long-acting muscarinic antagonist in a single inhaler. The drug also demonstrated a significant improvement in lung function within five minutes after the first dose, according to the company.

Results from the KALOS and LOGOS trials were published in The Lancet Respiratory Medicine in February 2026. No new safety or tolerability signals were identified in the trials.

Trixeo is already approved in the US and Japan for asthma treatment and is under review in China. The drug is also approved for the treatment of chronic obstructive pulmonary disease in adults across 90 countries, including the US, EU, China, and Japan.

According to the press release, nearly 43 million people in Europe live with asthma, with approximately four million new diagnoses each year.