AstraZeneca’s Airsupra (albuterol/budesonide) has demonstrated promising outcomes in the BATURA Phase IIIb trial, achieving its primary endpoint by significantly and meaningfully reducing the risk of severe asthma exacerbations when used as an as-needed rescue medication compared to albuterol alone. This trial focused on patients with intermittent or mild persistent asthma, including those utilizing short-acting beta2-agonists (SABA) only, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy.
Asthma, a chronic inflammatory respiratory condition, affects approximately 262 million people globally, with over 25 million cases reported in the United States. Notably, individuals with mild asthma account for at least 50% of the asthma population in the U.S. and face a heightened risk of severe exacerbations.
James Donohue, Emeritus Professor of Pulmonary Medicine at the University of North Carolina and Chair of the Independent Data Monitoring Committee, remarked, “Asthma patients are susceptible to severe exacerbations regardless of the severity or control of their condition. The robust results from the BATURA trial highlight the significant clinical benefits of an anti-inflammatory rescue approach for those with intermittent or mild persistent asthma, effectively addressing both symptoms and inflammation concurrently.”
Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca, added, “The impressive results from the BATURA trial bolster the evidence supporting Airsupra as a groundbreaking rescue treatment. It underscores its effectiveness in mitigating asthma exacerbations across varying disease severities and in decreasing the reliance on systemic corticosteroids.”
The BATURA trial confirmed that Airsupra’s safety and tolerability align with its established profile, and no new safety concerns were identified. The findings will be submitted to health authorities and presented in a late-breaking oral session at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.
Airsupra is the first and only anti-inflammatory rescue medication approved in the United States for as-needed treatment or prevention of bronchoconstriction, as well as for reducing the risk of exacerbations in adults aged 18 and older. Its U.S. approval was based on findings from the MANDALA and DENALI Phase III trials. Additionally, Airsupra is under investigation for use in adolescents aged 12 to under 18 years in the ACADIA Phase III trial.
