FDA Approves First-in-Class Fixed Dose Combination Rescue Medication for Asthma

Formerly known as PT027, albuterol/budesonide (Airsupra) has been approved by the FDA for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adults with asthma.¹

The approval was based on results from the MANDALA and DENALI phase 3 clinical trials (NCT03769090, NCT03847896). Albuterol/budesonide 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 MANDALA. It also demonstrated a significant reduction of mean annualized total systemic corticosteroid exposure at the approved dose of 180 mcg albuterol/160 mcg budesonide. In DENALI, albuterol/budesonide significantly improved lung function compared to albuterol and budesonide individually in patients with mild to moderate asthma.

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

Currently being developed by AstraZeneca and Avillion, albuterol/budesonide is a pressurized metered-dose inhaler, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid.

“With patients experiencing more than 10 million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US 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 US. Physicians will be able to offer their patients [albuterol/budesonide], an important new rescue treatment that reduces the risk of asthma exacerbations,” said Mene Pangalos, executive vice president of bioharmaceuticals research and development at AstraZeneca.

Reference

1. Airsupra (PT027) approved in the US for asthma. News Release. AstraZeneca. January 11, 2023. Accessed January 11, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html