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AstraZeneca's asthma maintenance treatment receives US FDA approval
By Iain Gilbert
Date: Tuesday 28 Apr 2026
(Sharecast News) - Drugmaker AstraZeneca said on Tuesday that it asthma maintenance treatment Breztri Aerosphere had received approval from the US Food and Drug Administration for adults and adolescents aged 12 and over.
AstraZeneca said the latest approval from the FDA was supported by data from its recent Phase III KALOS and LOGOS trials, which assessed Breztri in a broad asthma population, including patients with and without recent exacerbations.
In both studies, AstraZeneca said the therapy delivered "a statistically significant and clinically meaningful improvement" in lung function compared with dual‑combination ICS/LABA treatments.
The FTSE 100-listed firm also said Breztri showed a rapid onset of action, with a significant improvement in lung function seen within five minutes of the first dose.
AstraZeneca highlighted that its fixed‑dose triple‑combination single‑inhaler therapy was already approved in the US for chronic obstructive pulmonary disease and was prescribed to more than 6.8m patients globally in 2025.
Ruud Dobber, executive vice president of AstraZeneca's biopharmaceuticals business unit, said: "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."
As of 0915 BST, AstraZeneca shares were down 1.53% at 13,758p.
Reporting by Iain Gilbert at Sharecast.com
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