AstraZeneca's Trixeo Aerosphere wins EU approval as asthma maintenance therapy

European Commission clears Trixeo for uncontrolled asthma

AstraZeneca announced that the European Commission approved Trixeo Aerosphere as a maintenance treatment for asthma in patients aged 12 years and older whose condition is not adequately controlled with a medium-dose inhaled corticosteroid (ICS) plus long-acting beta2-agonist (LABA) combination. The decision followed a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.

First triple-combination therapy for EU asthma patients

Trixeo Aerosphere is a fixed-dose triple-combination inhaler containing budesonide, glycopyrronium and formoterol fumarate, combining an ICS, a long-acting muscarinic antagonist and a LABA in a single device. AstraZeneca described it as the first and only triple-combination therapy approved in the European Union for asthma patients aged 12 and older, regardless of exacerbation history. The product is marketed as Breztri Aerosphere in the United States, China and Japan.

Phase III KALOS and LOGOS data underpinning the label

The EU approval is supported by results from the Phase III KALOS and LOGOS trials, which enrolled approximately 4,300 patients over durations ranging from 24 to 52 weeks. The studies showed statistically significant lung-function improvements versus combined ICS/LABA comparators, with significant improvement from baseline observed within five minutes of the first dose. A pooled analysis also showed a statistically significant reduction in the annualised rate of severe asthma exacerbations, including among patients who had not experienced exacerbations in the prior year, and no new safety or tolerability signals were identified. Trixeo is a maintenance therapy and is not intended to treat sudden breathing problems.

Addressable patient population and broader portfolio reach

According to figures cited by AstraZeneca, nearly 43 million people in Europe are living with asthma, and many continue to experience uncontrolled symptoms despite existing treatment options. Trixeo/Breztri is already approved for asthma in the United States and Japan and remains under regulatory review in China and several other markets. The inhaler is also approved for chronic obstructive pulmonary disease (COPD) in more than 90 countries, and the new EU authorisation adds an indication to AstraZeneca's Respiratory & Immunology portfolio.

Next step in the rollout

Trixeo/Breztri remains under regulatory review for asthma in China and additional markets, with those decisions the next measurable milestones beyond the EU approval.