AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate) has been approved in the EU as a maintenance treatment for asthma in patients aged 12 years and older whose disease is not adequately controlled with a medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).
The fixed-dose triple combination is the first and only triple therapy approved in the EU for this patient population, irrespective of previous exacerbation history.
Trixeo combines an ICS and LABA with a long-acting muscarinic antagonist (LAMA) in a single Aerosphere pressurised metered-dose inhaler (pMDI).
The European Commission’s decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), based on results from the Phase III KALOS and LOGOS trials.
The studies showed statistically significant improvements in lung function compared with ICS/LABA dual therapies, while pooled data demonstrated a significant reduction in the annualised rate of severe asthma exacerbations.
The approval expands Trixeo’s established use in respiratory medicine. The therapy is already approved for COPD in more than 90 countries and was prescribed to more than 6.8 million patients globally in 2025.
It is marketed as Breztri Aerosphere in the US, China and Japan, where it is also approved for asthma in patients aged 12 years and older.
AstraZeneca has a longstanding focus on respiratory medicines, with its portfolio spanning inhaled and biologic therapies for conditions including asthma and COPD.
The company is also transitioning its pMDI portfolio to a next-generation propellant with near-zero global warming potential.
Trixeo was the first AstraZeneca inhaled respiratory medicine to be approved in the UK with the new propellant, which the company says offers a 99.9% reduction in global warming potential compared with conventional pMDI propellants.
