FDA approves AstraZeneca’s Breztri Aerosphere, a triple-combination inhaler, for maintenance treatment of asthma in patients aged 12 years and older.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration (FDA) has approved AstraZeneca’s fixed-dose triple-combination therapy, Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate), for the maintenance treatment of asthma in patients aged 12 years and older.
Breztri is a single-inhaler therapy that combines an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), integrating three established mechanisms used in respiratory care.
It was previously approved in the US in 2020 for chronic obstructive pulmonary disease (COPD) and has been widely used, with more than 6.8 million patients treated globally in 2025.
The approval is based on data from the Phase III KALOS (NCT04609878) and LOGOS trials (NCT04609904), which evaluated the therapy in a broad asthma population, including patients with and without recent exacerbations.
In these studies, Breztri showed statistically significant and clinically meaningful improvements in lung function compared with dual-combination ICS/LABA therapies, along with a rapid onset of action demonstrated by improvements within five minutes of the first dose.
No new safety or tolerability concerns were identified, and results were published in The Lancet Respiratory Medicine in February 2026.
Breztri is indicated as a maintenance therapy and is not intended for the relief of acute symptoms or as a replacement for rescue inhalers. Asthma affects approximately 27 million people in the US, and around half remain uncontrolled despite dual therapies, contributing to persistent symptoms and an estimated 10 million asthma attacks annually.
Njira Lugogo MD, Clinical Professor from University of Michigan noted that many patients continue to experience exacerbations and daily breathing difficulties despite existing treatments and described the approval of triple therapy for patients aged 12 years and older as an important step toward improving disease control.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca stated that the therapy has already shown benefits in COPD and that its expansion into asthma reflects ongoing efforts to address unmet needs in respiratory disease.
Breztri is currently approved for COPD in 90 countries, including the US, EU, China and Japan, and regulatory submissions for its use in asthma are under review in other major markets.
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