LONDON (dpa-AFX) - AstraZeneca PLC (AZN) on Tuesday said its triple-combination therapy Breztri Aerosphere has been approved by the U.S. Food and Drug Administration for the maintenance treatment of asthma in patients aged 12 years and older.
The therapy is a single inhaler combining an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) with a long-acting muscarinic antagonist (LAMA).
The approval was based on Phase III KALOS and LOGOS trials, where Breztri (budesonide/glycopyrrolate/formoterol fumarate) showed statistically significant and clinically meaningful improvements in lung function compared with dual-combination ICS/LABA treatments across a broad asthma population.
Breztri was already approved in the U.S. in 2020 for the treatment of adults with chronic obstructive pulmonary disease (COPD).
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