Shots:

• The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies- which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials
• P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi Aerosphere over 52wks. In both trials- the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators
• Trixeo Aerosphere is a single-inhaler- fixed-dose triple combination of formoterol fumarate- glycopyrronium bromide with budesonide- delivered in a pressurized metered-dose inhaler- and is approved under the brand name Breztri Aerosphere in Japan- China & the US for COPD

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