AstraZeneca FDA Approves Airsupra Label Update for Mild Asthma Benefits

AstraZeneca has announced that the FDA has approved an updated label for Airsupra, a medication for asthma. The label now includes benefits for mild asthma patients. AstraZeneca is a leading pharmaceutical company with net sales of $39.3 billion in 2022, primarily generated from product sales in the oncology, cardiovascular, respiratory, and autoimmune disease treatment areas.

The US Food and Drug Administration (FDA) has approved an updated label for AstraZeneca's Airsupra, a medication used for asthma. The new label includes clinically meaningful evidence from the BATURA study, demonstrating significant benefits for patients with mild asthma AIRSUPRA® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol^[1].

AIRSUPRA, a fixed-dose combination of albuterol and budesonide, is now supported by the BATURA Phase IIIb trial, which showed a 46% reduction in the risk of severe exacerbations compared to albuterol in adult patients with mild asthma AIRSUPRA® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol^[1]. The trial also demonstrated a reduction in the annualized severe exacerbation rate and in the annualized systemic steroid dose. These results were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco.

The initial US approval of AIRSUPRA was based on results from the Phase III MANDALA trial and Phase III DENALI trial. The new label update now includes the BATURA trial, which further supports the use of AIRSUPRA across all asthma severities.

AstraZeneca, a leading pharmaceutical company with net sales of $39.3 billion in 2022, primarily generated from product sales in the oncology, cardiovascular, respiratory, and autoimmune disease treatment areas, is commercializing AIRSUPRA. The company has extended its agreement with Avillion to undertake the BATURA Phase IIIb trial, which aimed to further assess the role of AIRSUPRA in reducing the risk of asthma exacerbations.

The updated label for AIRSUPRA is a significant step forward in the treatment of asthma, particularly for patients with mild asthma. It aligns with the Global Initiative for Asthma (GINA) recommendations, which support an anti-inflammatory rescue approach for adults of all asthma severities.