AstraZeneca has announced its fixed-dose triple-combination therapy Breztri Aerosphere has been approved by the US Food and Drug Administration (FDA) for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older in the US.
Breztri is a single-inhaler that combines the efficacy of corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA).
It was originally approved in the US in 2020 to treat adults with chronic obstructive pulmonary disease (COPD) and was prescribed to more than 6.8 million patients globally in 2025.
In the US, approximately 27 million people are living with asthma and around half of them remain uncontrolled despite being on dual therapies.
This can lead to inflammation and muscle tightening in the airways (bronchoconstriction), resulting in symptoms such as wheezing, breathlessness, chest tightness, coughing exacerbations and, in severe cases, even death.
Each year, nearly 10 million asthma attacks occur in the US.
The FDA based its approval on efficacy and safety data from the Phase III KALOS and LOGOS trials investigating Breztri in a broad population of patients with asthma, in which the therapy demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual-combination inhaled ICS/LABA.
In a key secondary endpoint, Breztri also demonstrated a rapid onset of action, with a significant improvement from baseline in lung function within five minutes after the first dose.
Though the company notes that Breztri is a maintenance therapy and is not to be used to relieve sudden breathing problems and will not replace a rescue inhaler.
Dr Njira Lugogo, Clinical Professor, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, said: "Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms."
The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, added: "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.
Regulatory filings for Breztri in asthma are currently under review in other major regions, including the EU, Japan and China.