AstraZeneca's (NASDAQ: AZN) fixed-dose triple-combination inhaler Trixeo Aerosphere has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union as a maintenance treatment for asthma in patients 12 years and older.

The recommendation covers patients not adequately controlled by a combination of a medium-dose inhaled corticosteroid and long-acting beta2-agonist. Trixeo Aerosphere combines an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist in a single inhaler.

The CHMP based its positive opinion 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 both trials also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations across a broad patient population, including those with no prior exacerbation history.

As a key secondary endpoint, the drug demonstrated improvement in lung function within five minutes after the first dose. No new safety or tolerability signals were identified in the trials. Results from both trials were published in The Lancet Respiratory Medicine in February 2026.

The drug is marketed as Breztri Aerosphere in the US, China, and Japan. It is approved in the US for asthma treatment, with regulatory filings under review in Japan and China. Trixeo/Breztri is also approved for 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.