AstraZeneca Expands Breztri’s Reach With FDA Approval for Asthma

AstraZeneca has secured another major milestone for its respiratory portfolio after the U.S. Food and Drug Administration approved Breztri Aerosphere as a maintenance treatment for asthma in patients aged 12 and older.

Originally approved in 2020 for chronic obstructive pulmonary disease (COPD), Breztri combines budesonide, glycopyrrolate, and formoterol fumarate in a single inhaler. The latest approval significantly expands the drug’s commercial potential as AstraZeneca continues to strengthen its respiratory business and pursue its long-term ambition of reaching $80 billion in annual revenue by 2030.

The approval follows positive results from the Phase III KALOS and LOGOS studies, which evaluated Breztri in a broad asthma population. According to AstraZeneca, the therapy demonstrated statistically significant improvements in lung function compared to standard dual-combination therapies (ICS/LABA), while also showing rapid onset of action within minutes of the first dose.

The opportunity is substantial. Around 27 million people in the U.S. live with asthma, and many continue to struggle with symptom control despite existing dual therapies. Expanding access to triple-combination treatments could help address a major unmet need in respiratory care.

Breztri has already become one of AstraZeneca’s key growth drivers, surpassing $1 billion in annual sales in 2025, with revenue growth exceeding 20% year-over-year. The company is also pursuing additional asthma approvals globally, including in Europe, Japan, and China.

The approval further reinforces the growing importance of respiratory innovation within pharma, where advanced combination therapies, precision medicine, and large-scale manufacturing capabilities are increasingly shaping competitive advantage and patient access.