AstraZeneca has received European Union approval for Trixeo Aerosphere as maintenance treatment for asthma in patients aged 12 and older whose symptoms are not adequately controlled with other therapies. It is the first EU approval of a single-inhaler triple therapy for this patient group.
The decision was based on results from the KALOS and LOGOS Phase III trials, which showed significant lung-function improvements compared with dual-therapy inhalers.
Trixeo is already approved for asthma in the U.S. and Japan, and for chronic obstructive pulmonary disease (COPD) in many countries. The EU decision expands AstraZeneca’s respiratory franchise.