AstraZeneca won European Commission approval for Trixeo Aerosphere, the same inhaler marketed as Breztri in the US, for maintenance treatment of asthma in patients 12 years and older.
The EU approval is based on positive Phase III KALOS and LOGOS trial results, which showed improved lung function and reduced severe asthma exacerbations versus dual ICS/LABA comparators.
The company said Trixeo/Breztri is the first and only triple-combination inhaler approved in the EU for this asthma population, regardless of prior exacerbation history.
This marks Breztri/Trixeo’s third major asthma approval after earlier clearances in the US and Japan, with China still under review for the asthma indication.
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Trixeo approved in the EU for the maintenance treatment of asthma
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