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# AstraZeneca’s Breztri Approved for COPD
- URL: https://www.fdaweb.com/astrazenecas-breztri-approved-for-copd/
- Published: 2020-07-24T12:00:00.000Z
- Updated: 2026-09-14T16:22:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147278

FDA has approved an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease. Approval was based on data from the Phase 3 ETHOS trial that demonstrated Breztri Aerosphere had a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies. The approval was also supported by efficacy and safety data from the Phase 3 KRONOS trial. The company says that the combination product is not indicated for relieving acute bronchospasm or for treating asthma.