FDA clears AstraZeneca’s Airsupra

Airsupra (albuterol/budesonide) has been approved by the Food and Drug Administration for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in individuals with asthma aged 18 years old and older.

Airsupra is a first-in-class, pressurized metered-dose inhaler, fixed-dose 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.

[Read more: AstraZeneca given FDA approval for Evusheld]

“With patients experiencing more than 10 million asthma exacerbations each year in the United States and uncontrolled asthma expected to cost the U.S. economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the United States,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.” 

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma,” said Bradley Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center in Sacramento. “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.”