FDA Approves Albuterol/Budesonide Rescue Medication for Asthma Exacerbations

The FDA has approved albuterol/budesonide (Airsupra; AstraZeneca) to prevent and treat bronchoconstriction on an as-needed basis. The drug was approved at a dose of 180 mcg albuteral/160 mcg budesonide based on the randomized, double-blind, multicenter, parallel-group, event-driven MANDALA and DENALI phase 3 trials.

Albuterol/budesonide (formerly called PT027) is a safe and tolerable first-in-class, pressurized metered-dose inhaler (pMDI). The rescue treatment combines albuterol, a short-acting beta2-agonist (SABA), with the anti-inflammatory inhaled corticosteroid (ICS), budesonide, to prevent the exacerbation of symptoms in moderate to severe asthma in adults aged 18 years and older.

“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,” Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, CA, said in a press release.

The rescue treatment met the study’s primary endpoint of time to first severe asthma exacerbation during treatment period. It also met secondary endpoints of mean annualized total systemic corticosteroid exposure, severe exacerbation rate, asthma control, and health-related quality of life.

Patients with asthma experience varied and recurrent breathlessness and wheezing. Any patient can experience exacerbations that create physical and emotional threats, including hospitalization, use of oral corticosteroid (OCS), and impaired quality of life. Single agent treatment with SABA (albuterol) has not been found to address the inflammation that is at the root of asthma and exacerbations, according to the study.

The MANDALA trial evaluated the safety and efficacy of the albuterol/budesonide combination rescue treatment against albuterol on time to first severe asthma exacerbation. The results showed that the rescue treatment could reduce the risk of severe exacerbation by 27% compared to albuterol alone.

The DENALI trial tested the dual treatment and lung function against its albuterol and budesonide components. The results show that albuterol/budesonide can significantly improve lung function, as measure by forced expiratory volume in 1 second.

“The approval of albuterol/budesonide (Airsupra) 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,” Chipps said in the press release.

Asthma is a chronic, inflammatory respiratory disease that affects more than 25 million people in the United States and 262 million worldwide. Nearly 8.5 million adults in the United States experience exacerbations, which can be fatal.

Albuterol/budesonide can alleviate severe symptoms. The most common adverse events in the trial included headache, oral candidiasis, cough, and dysphonia.

“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 (Airsupra), an important new rescue treatment that reduces the risk of asthma exacerbations, “said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in the press release.

Reference

AstraZeneca. Airsupra (PT027) approved in the US for asthma. News Release. 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