AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration has approved BREZTRI Aerosphere for the maintenance treatment of asthma in patients 12 years of age and older. The approval makes BREZTRI the first and only triple-combination therapy available for this patient population in the United States.

BREZTRI Aerosphere combines budesonide, glycopyrrolate and formoterol fumarate in a single inhaler. The drug was previously approved in the US in 2020 for treating adults with chronic obstructive pulmonary disease and has been prescribed to more than 6.8 million patients globally.

The FDA approval was based on data from two Phase III trials, KALOS and LOGOS, which included approximately 4,300 patients with asthma. The trials demonstrated statistically significant improvements in lung function compared with dual-combination inhaled therapy. BREZTRI also showed rapid onset of action with significant improvement in lung function within five minutes after the first dose.

According to the Centers for Disease Control and Prevention, 27 million people in the US live with asthma. The press release states that around half of asthma patients continue to be uncontrolled on dual therapies, and nearly 10 million asthma attacks occur annually in the US.

BREZTRI is currently approved for COPD treatment in 90 countries worldwide including the US, European Union, China and Japan. Regulatory filings for asthma treatment are under review in the EU, Japan and China.

The drug is contraindicated for primary treatment of acute asthma episodes and in patients with hypersensitivity to its components. Common adverse reactions include nasopharyngitis, pneumonia and headache for asthma patients.