AstraZeneca’s three-in-one inhaler Breztri Aerosphere has passed another significant milestone, inching towards the British drugmaker’s goal of reaching $80 billion in sales by 2030, after breaking the blockbuster sales benchmark in 2025.
On Tuesday, the FDA approved Breztri for a second indication, approving the triple combination of budesonide, glycopyrrolate, and formoterol fumarate as maintenance treatment for asthma in adults and children 12 years and older. Breztri was first approved in the United States in 2020 as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
The new agreement opens up a substantial market for Breztri, one of several respiratory products driving AstraZeneca’s big sales goals. Last year, the drug surpassed the $1 billion sales threshold for the first time, with revenue increasing 22% on a constant currency basis (PDF) to nearly $1.2 billion.
Additionally, the drug ranks among a roster of new AZ products to join the British drugmaker’s campaign to achieve a staggering $80 billion in sales by the end of 2010. The company’s chief financial officer, Aradhana Sarin, said at the JPMorgan Healthcare Conference in San Francisco that as of January, that goal still seemed “quite within reach.”
The FDA approved the new use of Breztri after reviewing data from a pair of Phase 3 trials, KALOS and LOGOS, which evaluated the triple inhaler in a broad population of asthma patients, with and without recent asthma exacerbations.
In this trial, Dr. Breztri demonstrated statistically significant and clinically meaningful improvements in lung function compared to a dual-drug control consisting of an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA), Dr. AZ said. In addition to its rapid onset of action, the drug also showed significant improvement from baseline in lung function within 5 minutes of the first dose.
AZ estimates that there are approximately 27 million people living with asthma in the United States, and about half of them struggle to control their symptoms with dual-drug therapy. The company added that approximately 10 million asthma attacks occur in the United States each year.
AZ noted that Breztri, as a maintenance therapy, is not indicated to relieve sudden breathing difficulties as a substitute for emergency inhalers.
Breztri is widely used for COPD around the world and is also pursuing approval for asthma in the European Union, Japan, China and other countries.
Besides Breztri, Tezspire, which is partnered with Fasenra and Amgen, form the other main pillars of AstraZeneca’s respiratory empire.
