FDA Updates Albuterol/Budesonide Label to Include Evidence of Exacerbation Risk Reduction in Mild Asthma

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The US FDA has approved a supplemental new drug application updating prescribing information for albuterol/budesonide (Airsupra^®, AstraZeneca), reflecting evidence from the phase 3b BATURA clinical trial that demonstrated significant benefit in adults with mild asthma.¹

"This label update approved by the FDA ensures that the critical evidence for AIRSUPRA in mild asthma is now included in the prescribing information, allowing physicians to make the most informed decisions about rescue medicine for their patients. This update, along with the recent GINA Report, supports an anti-inflammatory rescue approach for adults of all asthma severities," said Reynold A. Panettieri Jr, MD, vice chancellor and professor of medicine at Rutgers Institute for Translational Medicine and Science, said in a statement released by AstraZeneca.¹

In the study, as-needed use of albuterol/budesonide reduced the risk of severe asthma exacerbations by 46% compared with as-needed albuterol alone (hazard ratio, 0.54; 95% CI, 0.40-0.72; P<.001). The study included 2 421 participants aged 12 years and older, though albuterol/budesonide remains indicated for adults 18 years and older. Secondary endpoints showed reductions in annualized exacerbation rates and systemic corticosteroid use. Safety outcomes were consistent with the established profile of the medication. Results were published in the New England Journal of Medicine and presented at the American Thoracic Society 2025 International Conference.²

The new data build on prior findings from the phase 3 MANDALA and DENALI trials, which evaluated the combination therapy in patients with moderate to severe and mild to moderate asthma, respectively. Together, the trials support the use of albuterol/budesonide across the spectrum of asthma severity as an anti-inflammatory rescue approach.^3,4

The Global Initiative for Asthma (GINA) has advised against short-acting β₂-agonist (SABA)–only treatment since 2019 and in its 2025 report recommended an anti-inflammatory rescue strategy for adults with asthma of all severities.^5,6 The combination albuterol/budesonide therapy remains the first and only anti-inflammatory rescue inhaler approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risk in adults with asthma.⁷

Asthma affects approximately 27 million people in the US, with exacerbations contributing to hospitalizations, reduced quality of life, and mortality risk.^8,9 The incorporation of BATURA results into prescribing information may influence clinical decisions in primary care, particularly for adult patients with mild asthma who are at risk for exacerbations despite otherwise low daily symptom burden.

References:

1. AIRSUPRA ® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol. AstraZeneca. News release. September 18, 2025. Accessed September 18, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html
2. Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial. News release. AstraZeneca. October 7, 2024. Accessed October 7, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/airsupra-positive-results-phase-iii-batura-trial.html#!
3. Papi A, Chipps B, Beasley RW, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022;386:2071-2083.
4. Chipps BE, Israel E, Beasley RW, et al. Efficacy and Safety of Albuterol/Budesonide (PT027) in Mild-to-Moderate Asthma: Results of the DENALI Study. Am J Respir Crit Care Med. 2022;205:A3414.
5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2019. Accessed September 18, 2025. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf
6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2025. Accessed September 18, 2025. https://ginasthma.org/2025-gina-strategy-report/
7. FDA. FDA approves drug combination treatment for adults with asthma. News release. Updated January 11, 2023. Accessed September 18, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma
8. Global Asthma Network. The Global Asthma Report 2022. Accessed September 18, 2025. https://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf
9. CDC. Most recent national asthma data. [Online]. Updated November 21, 2024. Accessed September 18, 2025. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html