Airsupra (PT027) approved in the U.S. for asthma

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Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the U.S. 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 approval by the FDA was based on results from the MANDALA and DENALI Phase III trials. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to 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 to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide. In DENALI, Airsupra significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.

Airsupra is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid in the U.S. It is being developed by AstraZeneca and Avillion.

“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. The approval of Airsupra means that for the first time, adults with asthma in the U.S. have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease,” said Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center. 

“With patients experiencing more than 10 million asthma exacerbations each year in the U.S. 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 U.S. Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D, AstraZeneca. 

The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components, with the most common adverse events including headache, oral candidiasis, cough and dysphonia.

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


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