AstraZeneca’s Airsupra Shows Positive Results In Reducing Severe Asthma Attacks In Phase III Trials

AstraZeneca announces the positive results of the BATURA Phase IIIb trial for Airsupra (albuterol/budesonide) as it meets the primary endpoint by prominently reducing the risk of adverse asthma exacerbations when compared to albuterol. Patients with intermediate or mild persistent asthma, including those using short-acting beta2-agonists (SABA) alone, low-dose inhaled corticosteroids (ICS), or leukotriene receptor antagonist (LTRA) maintenance therapy, were included in the trial.

Asthma, a chronic inflammatory respiratory condition, affects up to 262 million people globally, with over 25 million cases in the US. Mild asthma patients account for at least 50% of the US asthma population and are still at risk for severe exacerbations. 

The safety and tolerability of Airsupra observed in the BATURA trial aligned with its previously established profile, with no new safety issues identified. This data will be submitted to health authorities and will be showcased as a late-breaking oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.

Airsupra is the first anti-inflammatory rescue medication approved in the US for the on-demand treatment and prevention of bronchoconstriction and to reduce asthma attacks risk in adults aged 18 and older. Its approval in the US was based on the successful MANDALA and DENALI Phase III trials. Airsupra is also being evaluated in adolescents in the ACADIA Phase III trial and patients in China through the BAIYUN Phase III trial. Airsupra is a joint development between AstraZeneca and Avillion.

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time,” said James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and Chair, Independent Data Monitoring Committee.

Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca, also stated: “The impressive BATURA trial results add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids.”