USFDAApr 28, 2026, 07:37 AM
AZN Breztri approved in US for asthma, first triple therapy for 12+
AI Summary
AstraZeneca's Breztri Aerosphere has received US FDA approval for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. This marks Breztri as the first and only single-inhaler fixed-dose triple therapy for asthma, building on its prior approval for COPD. The approval is supported by positive efficacy and safety data from the Phase III KALOS and LOGOS trials, which demonstrated significant improvements in lung function and a rapid onset of action.
Key Highlights
- Breztri approved in US for maintenance treatment of asthma in patients 12 years and older.
- First and only single-inhaler fixed-dose triple therapy for asthma patients.
- Approval based on efficacy and safety data from KALOS and LOGOS Phase III trials.
- Demonstrated statistically significant and clinically meaningful improvement in lung function.
- Showed rapid onset of action with significant lung function improvement within five minutes.
- Breztri (320/18/9.6lg) was previously approved in the US in 2020 for COPD.
- Prescribed to over 6.8 million patients globally in 2025 for COPD.
- Regulatory filings for Breztri in asthma are under review in EU, Japan, and China.