The FDA Approves AstraZeneca's Supplemental New Drug Application For Airsupra As Us Prescribing Information Now Includes Clinically Meaningful Evidence From BATURA Study In Patients With Mild Asthma

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