EU Regulators Back AstraZeneca’s Trixeo for Asthma

Overview

• The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on Thursday, July 23, 2026, recommending Trixeo Aerosphere be authorised for maintenance treatment of asthma in patients aged 12 and over.
• The recommendation includes a new inhaler strength of formoterol 5 µg, glycopyrronium 18 µg (equivalent to 14.4 µg glycopyrronium), and budesonide 160 µg for the pressurised inhalation suspension.
• CHMP based its opinion on pooled Phase III KALOS and LOGOS data from about 4,300 patients showing statistically significant lung function gains and a lower annualised rate of severe exacerbations versus medium‑dose ICS/LABA, with no new safety signals reported.
• Next steps require a formal decision by the European Commission and publication of an updated summary of product characteristics (SmPC) in EU languages before the new asthma indication and strength take effect.
• Trixeo, marketed as Breztri in some countries, is already approved for COPD in around 90 countries and was cleared for asthma by the FDA earlier in 2026, so an EU approval would widen a single‑inhaler triple option for patients who remain uncontrolled on dual therapy.