FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

The United States Food and Drug Administration (US FDA) has approved a supplemental new drug application (sNDA) for Astrazeneca’s albuterol/budesonide, currently approved under the name Airsupra, to expand its indication for 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,” Reynold A. Panettieri Jr, MD, Vice Chancellor and Professor of Medicine at Rutgers Institute for Translational Medicine and Science, said in a statement.1

The new label includes clinically meaningful evidence from the phase 3b BATURA study in patients with mild asthma. The trial demonstrated that albuterol/budesonide significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR], 0.54; 95% CI, 0.40-0.72; P <.001) compared with albuterol. Investigators also observed a reduction in the annualized severe exacerbation rate (0.15 vs. 0.32; rate ratio, 0.47; 95% CI, 0.34-0.64), and in annualized systemic steroid dose (23.2 vs. 61.9 mg per year). The therapy was well-tolerated, with safety findings consistent with its established safety profile.2

The initial US approval of albuterol/budesonide was based on results from the Phase 3 MANDALA and DENALI trials and Phase III DENALI trial (lung function trial in patients with mild to moderate asthma).3 In MANDALA, the therapy significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. It also demonstrated a significant reduction in the secondary endpoint of mean annualized total systemic corticosteroid exposure compared to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide. In DENALI, Airsupra significantly improved lung function compared to albuterol and budesonide separately in patients with mild to moderate asthma.

Albuterol/budesonide is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. AstraZeneca noted that the Global Initiative for Asthma (GINA) has recommended against SABA-only treatment of asthma in adults since 2019, and furthermore, the 2025 Report from GINA supports an anti-inflammatory rescue approach in adults of all asthma severities.

“Patients living with asthma deserve a treatment that offers more than just relief from their symptoms. With this label update for AIRSUPRA, which includes proven benefits for mild asthma, patients across all asthma severities have a superior choice for their asthma rescue medication,” Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca, added.1

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. News release. AstraZeneca. 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. LaForce C, Albers F, Danilewicz A, et al. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025;393(2):113-124. doi:10.1056/NEJMoa2504544

3. Airsupra (PT027) approved in the US for asthma. News release. AstraZeneca. January 11, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html#