AstraZeneca wins EU approval for Trixeo to treat asthma

AstraZeneca announced that the European Commission has approved its respiratory drug, Trixeo Aerosphere, for a new indication. The therapy is cleared in the European Union as a maintenance treatment for previously treated asthma patients aged 12 years and older who are not adequately controlled with inhaled corticosteroid and long-acting beta2-agonist therapies.

The clearance makes Trixeo the first and only triple-combination therapy approved in the European Union for this specific asthma population. The decision follows a positive recommendation issued in July by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The drug was already approved in the European Union for chronic obstructive pulmonary disease.

The approval is based on phase III KALOS and LOGOS clinical trials, where Trixeo significantly improved lung function compared with standard treatments and showed effects within five minutes of the first dose. A pooled analysis also demonstrated a significant reduction in severe asthma attacks, with no new safety or tolerability issues reported. Asthma affects nearly 43 million people across Europe.

Trixeo Aerosphere is sold as Breztri Aerosphere in the United States and Japan for asthma, while regulatory applications remain under review in China and other markets. Year to date, AstraZeneca shares have declined 7.5%, compared with an 8% gain for its industry peer group.