AstraZeneca’s Trixeo approved in EU for asthma in patients aged 12 and over
pharmafile | October 27, 2026 | News story | | Asthma & COPD, COPD, EMA, EU, Pharmacy, asthma
AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate) has been approved by the European Commission as a maintenance treatment for asthma in patients aged 12 and over whose condition is not adequately controlled with medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination therapy.
The single-inhaler triple combination adds a long-acting muscarinic antagonist (LAMA) to ICS/LABA treatment. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from the phase 3 KALOS and LOGOS trials.
Across the trials, Trixeo significantly improved lung function compared with combined ICS/LABA comparators. A pooled analysis also found a statistically significant reduction in the annualised rate of severe asthma exacerbations, including among patients who had not experienced an exacerbation in the previous year.
The trials also showed a significant improvement in lung function within five minutes of the first dose, a secondary endpoint. No new safety or tolerability signals were identified, according to AstraZeneca.
Professor Alberto Papi, Chair of Respiratory Medicine at the University of Ferrara and a primary investigator in the programme, said the approval offered a new single-inhaler option for patients whose asthma remains uncontrolled on dual therapy.
Trixeo is marketed as Breztri Aerosphere in the US, China and Japan. The product is already approved for chronic obstructive pulmonary disease (COPD) in adults in multiple markets, including the EU and US. It is also approved for asthma in the US and Japan, while its asthma application remains under review in China and other countries.
Trixeo is a maintenance treatment and is not intended to relieve sudden breathing problems or replace a rescue inhaler.
Pic: CNordicNordic
Related Content
Sobi’s olezarsen recommended for EU approval in severe hypertriglyceridaemia
Sobi’s olezarsen (TRYNGOLZA) has received a positive opinion from the European Medicines Agency’s Committee for …
How will biomarker-led diagnostics reshape respiratory medicine?
By Dr Louise Ryan Murphy, Chronic obstructive pulmonary disease (COPD) is typically diagnosed and assessed …
Five Facts about COPD
1 Chronic obstructive pulmonary disease is a group of progressive lung conditions, principally emphysema and …
