AstraZeneca (LSE:AZN) said the European Commission approved Trixeo Aerosphere as a maintenance treatment for asthma patients aged 12 and older whose condition remains uncontrolled on a combined inhaled corticosteroid and long-acting beta2-agonist.
The single inhaler combines that dual therapy with a long-acting muscarinic antagonist, making it the first triple-combination therapy approved in the EU for asthma regardless of a patient's exacerbation history.
The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, based on the Phase III KALOS and LOGOS trials covering roughly 4,300 patients.
In a pooled analysis, Trixeo showed a statistically significant reduction in the annualised rate of severe asthma exacerbations compared with combined ICS/LABA therapy, including in patients with no prior exacerbations.
"The approval of Trixeo in Europe as the first triple-combination therapy in a single inhaler for patients 12 years of age and older provides an important new treatment option," said Alberto Papi, professor of respiratory medicine at the University of Ferrara and the trials' primary investigator.
Ruud Dobber, AstraZeneca's president of BioPharmaceuticals, said the move builds on Trixeo's established role in chronic obstructive pulmonary disease.
Trixeo, sold as Breztri Aerosphere in the US, China and Japan, is already approved for COPD in more than 90 countries and was prescribed to more than 6.8 million patients globally in 2025.
The drug's asthma indication is also approved in the US and Japan, and remains under regulatory review in China and other markets.
News Intelligence what this means for the company
The European Commission approved Trixeo Aerosphere for asthma in patients aged 12 and over, making it the first triple-combination inhaler (ICS/LABA/LAMA) approved in the EU for this indication. The approval rests on Phase III data from roughly 4,300 patients showing statistically significant reduction in severe exacerbation rates versus dual therapy, and extends a drug already established in COPD—where it has been prescribed to more than 6.8 million patients globally in 2025 and approved in over 90 countries.
This approval opens a new indication for an already-commercialised asset with proven global uptake, reducing development risk and broadening the addressable patient base. The asthma approval in the EU follows earlier clearance in the US and Japan, signalling regulatory confidence across major markets.
Insights assembled by AI. Editor-reviewed and grounded in tickstock’s coverage and proprietary knowledge graph.
Content is for informational purposes only, not financial advice.