AstraZeneca : AIRSUPRA Gains FDA Label Update After Strong Results In Mild Asthma Patients

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(RTTNews) - AstraZeneca (AZN, AZN.L, ZEG.DE, AZN.ST) announced a major update to the U.S. prescribing information for AIRSUPRA, following new clinical evidence from the BATURA study. This Phase IIIb trial focused on adults with mild asthma and compared AIRSUPRA, used as needed, with albuterol—the most widely used rescue inhaler in the country. The results were striking: AIRSUPRA reduced the risk of severe asthma attacks by 46%, showing a clear advantage over albuterol.

This new data builds on earlier findings from the MANDALA Phase III trial, which studied patients with moderate to severe asthma. Together, the MANDALA and BATURA trials confirm that AIRSUPRA offers consistent protection against severe asthma exacerbations across all levels of severity, the company said.

In addition to meeting its main goal of reducing severe attacks, the BATURA study also showed a drop in the yearly rate of exacerbations and a decrease in the use of systemic steroids. Importantly, AIRSUPRA maintained its strong safety profile throughout the study.

AIRSUPRA was originally approved in the U.S. based on results from the MANDALA and DENALI trials, which focused on lung function and asthma control in patients with mild to moderate symptoms. With the addition of BATURA, AIRSUPRA's label now reflects its benefits for mild asthma as well.

AIRSUPRA was developed by AstraZeneca and Avillion.

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