AstraZeneca announced that the FDA has approved the company’s supplemental NDA to add data related to the treatment of mild asthma to the label for Airsupra albuterol / budesonide MDI. In October 2024, AstraZeneca and Avillion Life Sciences announced that the Phase 3 BATURA trial of Airsupra in patients with mild asthma had met its primary endpoint, demonstrating a significant reduction in the risk of experiencing a severe exacerbation for Airsupra compared to albuterol alone.
Avillion partnered with AstraZeneca subsidiary Pearl Therapeutics on development of the MDI in 2018, and Airsupra was approved by the FDA in January 2023 for the treatment of asthma in patients aged 18 and over.
AstraZeneca VP, US Respiratory and Immunology, Liz Bodin commented, “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.”
Read the AstraZeneca press release
