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AstraZeneca received European Commission approval for Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate…
AZNAstrazeneca PLC
AstraZeneca received European Commission approval for Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate) as a maintenance treatment for asthma in patients aged 12 and older. This marks the first triple-combination therapy approved in the EU for this indication, regardless of exacerbation history. The approval follows positive opinions from the EMA's CHMP based on Phase III KALOS and LOGOS trials involving approximately 4,300 patients, which demonstrated statistically significant improvements in lung function and reductions in severe asthma exacerbations compared to dual ICS/LABA therapies. Trixeo is marketed as Breztri Aerosphere in the US, China, and Japan for both asthma and COPD treatment. AstraZeneca PLC operates in the global biopharmaceutical industry, focusing on the discovery, development, and commercialization of prescription medicines.