FDA Approves Rescue Combination Medication for Asthma

The FDA has approved Airsupra (albuterol/budesonide) as an as-needed treatment to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid. It is being developed by AstraZeneca and Avillion.

Bradley E. Chipps, M.D.

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control,” Bradley E. Chipps, M.D., past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center. “Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that for the first time, adults with asthma in the United States have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.”

In the United States, AstraZeneca will provide Airsupra to healthcare practitioners upon request for appropriate patients, and it will be commercially available in the first quarter of 2024, according to a company spokesperson.

AstraZeneca would not provide a list price, but the spokesperson said “the price of Airsupra in the U.S. reflects the value of the product, and as with all our medicines, we are committed to making sure that the patients who are prescribed our medicines have affordable access to them. When making any pricing decision, we aim to do so responsibly and in line with current treatment costs.”

The approval was based on results from the MANDALA and DENALI phase 3 trials. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared with albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. In the secondary endpoint of mean annualized total systemic corticosteroid exposure, Airsupra demonstrated a significant reduction compared with albuterol at the approved dose of 180mcg albuterol/160mcg budesonide. In DENALI, Airsupra significantly improved lung function compared were the individual components albuterol and budesonide in patients with mild-to-moderate asthma.

Results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.