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# AstraZeneca Asthma Drug Approved by FDA
- URL: https://www.fdaweb.com/astrazeneca-asthma-drug-approved-by-fda/
- Published: 2023-01-11T12:00:00.000Z
- Updated: 2026-09-14T18:11:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153517

FDA has approved an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The pressurized metered-dose inhaler contains a short-acting beta2-agonist (albuterol) and an anti-inflammatory inhaled corticosteroid (budesonide).

It is the first combination of an inhaled corticosteroid (ICS) and a short-acting beta-agonist to be approved in the U.S., an [FDA release](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Additionally, Airsupra is the first product containing an ICS to be approved in the U.S. as a reliever treatment (rather than as a controller) for asthma,” it adds.

The approval was based on data from the MANDALA and DENALI Phase 3 trials. In MANDALA, the product was shown to significantly reduce the risk of severe exacerbations compared to albuterol alone in patients with moderate to severe asthma when used as an as-needed rescue medication, the company says. In DENALI, Airsupra significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma, it says.

The product was developed by AstraZeneca and Avillion.