AstraZeneca announced that the FDA has approved the company’s Breztri Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older. The agency originally approved Breztri for the treatment of COPD in July 2020.
AstraZeneca had announced in May 2025 that both of its Phase 3 trials comparing Breztri to inhaled ICS/LABA in patients with uncontrolled asthma (KALOS and LOGOS) had met their primary endpoints. The version of Breztri for the treatment of asthma contains twice the dose of glycopyrrolate compared to the inhaler for the treatment of COPD.
According to the company, Breztri (Trixeo) is currently approved for the treatment of COPD in 90 countries and submissions for the asthma indication are under review in the EU, Japan, and China, among other markets. AstraZeneca has also been developing an LGWP formulation of the Breztri / Trixeo using HFO-1234ze as the propellant. That version of Trixeo Aerosphere was approved in the UK in May 2025 for the treatment of COPD.
AZ Executive VP, BioPharmaceuticals Business Unit, Ruud Dobber commented, “As the fastest growing fixed-dose triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients. The FDA’s approval of Breztri in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”
Read the AstraZeneca press release
