The US FDA approved a supplemental new drug application for Airsupra, expanding the drug’s reach to all asthma patients age 18+.


The US FDA approved a supplemental new drug application for Airsupra (albuterol/budesonide) and updated its US prescribing information to reflect new data in patients with mild asthma. The approval expands Airsupra as an anti-inflammatory rescue approach for adults across all asthma severities, according to AstraZeneca.

Key Highlights

  • Airsupra’s US prescribing information now includes statistically significant and clinically meaningful updates from the BATURA Phase IIIb study, published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference.
  • The BATURA trial demonstrated treatment with Airsupra significantly reduced the risk of a severe exacerbation by 46% when compared with albuterol alone in adult patients with mild asthma.
  • This builds upon the previous MANDALA Phase III trial in adult patients with moderate to severe asthma, demonstrating the benefit of as-needed Airsupra across all asthma severities compared to albuterol alone.

Airsupra’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.1 The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed Airsupra compared to as-needed albuterol,2 the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with Airsupra significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% confidence interval [CI]: 0.40, 0.72; p<0.001) when compared with albuterol in adult patients with mild asthma.2

The inclusion of BATURA study results in the US prescribing information builds upon the previous MANDALA Phase III trial in adult patients with moderate to severe asthma.3 The MANDALA and BATURA clinical trials demonstrate the benefit of as-needed Airsupra in reducing the risk of severe exacerbations across all asthma severities compared to albuterol.2-3

In BATURA, Airsupra demonstrated a significant reduction in the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% CI: 0.40, 0.72; p<0.001) when compared to albuterol in adult patients with mild asthma.2 In addition to achieving the primary endpoint, a reduction in the annualized severe exacerbation rate and in annualized systemic steroid dose were also observed.2 These positive results from BATURA were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco. Safety findings in the BATURA trial demonstrated the safety and tolerability of Airsupra. Thus, Airsupra was consistent with its established safety profile.2

The initial US approval of Airsupra was based on results from the Phase III MANDALA trial and Phase III DENALI trial (lung function trial in patients with mild to moderate asthma), and now includes the addition of BATURA, a Phase IIIb trial in patients with mild asthma.2-4  

The Global Initiative for Asthma (GINA) has recommended against SABA-only treatment of asthma in adults since 2019.5 The 2025 Report from GINA supports an anti-inflammatory rescue approach in adults of all asthma severities.6 Airsupra is the first and only anti-inflammatory rescue medication approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.1,7

Dr. Reynold A. Panettieri Jr, Vice Chancellor and Professor of Medicine at Rutgers Institute for Translational Medicine and Science, said: “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.”

Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca said: “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.”

AIRSUPRA was developed by AstraZeneca and Avillion.    

APPROVED USE

AIRSUPRA combines two medicines to be used as needed as a rescue inhaler in people 18 years of age and older to:

  • treat or prevent symptoms of asthma
  • help prevent sudden severe breathing problems (asthma attacks or exacerbations)