By VETTAPHARMA reporter – Derek Roche: AstraZeneca’s Breztri Aerosphere has been approved in the United States for the maintenance treatment of asthma in patients aged 12 years and older, marking an important expansion in its respiratory portfolio.
Breztri is a fixed-dose triple-combination therapy comprising budesonide, glycopyrronium, and formoterol fumarate dihydrate (320/28.8/9.6 micrograms) delivered via a single inhaler. The approval extends its use beyond chronic obstructive pulmonary disease (COPD), where it was previously indicated.
The approval is supported by results from the Phase III KALOS and LOGOS trials, which evaluated the therapy in patients with uncontrolled asthma. The studies demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.
These trials included patients whose asthma remained uncontrolled despite standard treatment, highlighting a persistent unmet need. Breztri showed rapid and sustained improvements in lung function, with a safety profile consistent with the known effects of its individual components.
Asthma affects approximately 27 million people in the United States, with many patients continuing to experience inadequate disease control. The availability of a single-inhaler triple therapy introduces a new treatment option aimed at improving outcomes in this population.
From a commercial perspective, this approval expands Breztri’s addressable market beyond COPD into asthma, a significantly larger patient population. This broader indication is expected to strengthen AstraZeneca’s respiratory franchise and may contribute to incremental revenue growth, particularly given the scale of uncontrolled asthma patients eligible for advanced therapies.
