WILMINGTON, DE — The U.S. prescribing information for AIRSUPRA now includes results from the Phase IIIb BATURA trial, which demonstrated that the medication significantly reduced severe asthma exacerbations in patients with mild disease compared to albuterol.
The study showed that as-needed AIRSUPRA cut the risk of a severe exacerbation by 46% (hazard ratio 0.54; 95% CI: 0.40–0.72; p<0.001) in adults with mild asthma. Results were published in the New England Journal of Medicine and presented at the 2025 American Thoracic Society International Conference.
The update builds on earlier approvals based on the MANDALA and DENALI trials, which established AIRSUPRA’s efficacy in patients with moderate to severe asthma and in improving lung function in mild to moderate cases. Together, the findings confirm benefits across the full spectrum of asthma severity.
“This label update ensures physicians have access to critical evidence when making decisions about rescue medicine for patients with mild asthma,” said Dr. Reynold A. Panettieri Jr., Vice Chancellor at Rutgers Institute for Translational Medicine and Science.
Liz Bodin, Vice President, U.S. Respiratory & Immunology at AstraZeneca, added that the expansion “gives patients across all asthma severities a superior choice for rescue medication.”
The Global Initiative for Asthma (GINA) has recommended against short-acting beta agonist (SABA)-only treatment in adults since 2019, advocating for anti-inflammatory rescue therapy. AIRSUPRA remains the first and only FDA-approved anti-inflammatory rescue medication for as-needed use in adults 18 and older, designed to reduce exacerbation risk while providing symptom relief.
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