FDA Approves AstraZeneca’s Airsupra as Reliever Asthma Treatment

The FDA has approved AstraZeneca’s Airsupra (albuterol and budesonide) inhalation aerosol for an as-needed treatment for prevention of bronchoconstriction and reduction of exacerbation risks in people 18 years and older with asthma.

The approval is the first for a product that combines the corticosteroid budesonide with albuterol, a short-acting beta-agonist, which works to relax the muscles and reduce inflammation in the lung airways to reduce the risk of severe asthma attacks.

The approval was based on positive results from four phase 3 studies with 4,000 participants in which the treatment reduced severe exacerbations by 27 percent.

Airsupra is the result of a collaboration between AstraZeneca and UK-based Avillion, a drug development company that conducted the clinical studies.