AstraZeneca announced that the European Commission has approved the company’s Trixeo (Breztri) Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older whose asthma is not adequately controlled by an ICS/LABA combination. In the US, the FDA approved Breztri Aerosphere for the asthma indication in April 2026.
Trixeo / Breztri was approved for the treatment of COPD in both Europe and in the US in 2020. In May 2025, AstraZeneca announced that both the KALOS and LOGOS Phase 3 trials that compared Trixeo / Breztri to inhaled ICS/LABA in patients with uncontrolled asthma met their primary endpoints.
AstraZeneca is also developing an LGWP version of Breztri / Trixeo formulated with HFO-1234ze that has already been approved in the UK and in Australia for the treatment of COPD. In Europe, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the LGWP version of Trixeo in July 2025.
AstraZeneca Executive VP, BioPharmaceuticals Business Unit, Ruud Dobber commented, “Today’s approval in asthma builds on Trixeo’s established role in improving outcomes in patients with COPD. This means we can now bring the benefits of a single inhaler triple combination therapy to people aged 12 years and older in Europe whose asthma remains uncontrolled on dual inhaled therapy.”
Read the AstraZeneca press release
