AstraZeneca’s triple-combination asthma therapy Breztri Aerosphere was approved in April 2026 for adults and pediatric patients age 12 and older.
RT’s Three Key Takeaways:
- Triple Therapy Access: Breztri Aerosphere is now commercially available in the US as a maintenance treatment for asthma patients 12 years of age and older.
- Improved Lung Function: Phase III clinical trials demonstrated that the three-in-one inhaler provided significant improvements in lung function compared to dual-combination therapies.
- Expanded Indication: The medication, which was previously approved for chronic obstructive pulmonary disease, offers a new approach for asthma patients who remain symptomatic on other treatments.
AstraZeneca’s fixed-dose triple-combination therapy, Breztri Aerosphere, is now commercially available in the US by prescription for the maintenance treatment of asthma in patients 12 years of age and older, according to the company.
The FDA granted approval for the indication in April 2026. The product is a three-in-one maintenance inhaler that combines a corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist. According to the company, the therapy is not indicated for the relief of sudden breathing problems and will not replace a rescue inhaler.
The FDA based its approval on results from two Phase III trials, KALOS and LOGOS, which studied a broad population of patients with asthma. In these trials, the triple therapy demonstrated significant lung function improvement when compared with dual-combination inhaled therapies, the company stated.
This availability marks the second indication for the medication in the US. It was previously approved in 2020 to treat adults with COPD.
“Breztri’s availability represents continued progress made for asthma care for both adolescents and adults, which not only helps patients manage their symptoms, but also can help alleviate the impact that asthma can have on their personal and professional lives,” said Priya Bansal, physician and CEO of the Asthma and Allergy Wellness Center, in a news release. “Now, by making another option available, patients can have greater choice as they seek treatment with their healthcare providers.”
The company is also offering a co-pay assistance program for eligible patients to increase access to the medication.
“We’re thrilled to be able to offer Breztri to asthma patients in the US. This availability is the latest step in our commitment to providing transformative respiratory care, empowering patients to seek treatment options tailored to their unique asthma journeys,” said James Teague, vice president of US respiratory & immunology and vaccine & immune therapies.
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