Combination Albuterol/Budesonide Rescue Medication for Adults with Asthma Now Available

Airsupra (albuterol/budesonide) is now commercially available in the US, indicated as an as-needed treatment for prevention of bronchoconstriction and to reduce the risk of exacerbations in adults with asthma aged 18 years and older.¹

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Developed by AstraZeneca and Avillion and approved by the US Food and Drug Administration in January 2023, albuterol/budesonide is a first-in-class, pressurized metered-dose inhaler combination rescue medication that contains the short-acting beta2-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide.¹ It is the first approved medication to combine the 2 drug classes and the first product containing an ICS to gain US FDA approval as a reliever treatment as compared to a controller treatment for asthma.²

“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 US 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 in Sacramento, CA, in an AstraZeneca statement.³

New thoughts on rescue treatment

The albuterol/budesonide approval reflects the shift in approach to treating asthma symptoms with rescue medication. Guidelines issued in 2023 by the Global Initiative for Asthma (GINA) now support an approach to rescue treatment that simultaneously addresses acute symptoms and the underlying inflammation characteristic of asthma.⁴ GINA recommends the SABA/ICS combination as a rescue treatment option for adults with asthma regardless of their use of ICS maintenance medication.⁴ According to GINA, recommendations for a change in rescue approach were largely based on the risks associated with overuse of SABA-only treatments, which had been linked to worsening symptoms and to poor overall asthma outcomes.⁴

“For more than five decades, the medical community has used SABA-only (short-acting beta agonist) rescue, which does not address the inflammatory component of asthma,” Priya Bansal, MD, CEO of Asthma and Allergy Wellness Center in St Charles, IL, said in the announcement.¹ “The MANDALA study has demonstrated how these patients can benefit from an as-needed anti-inflammatory rescue to treat their symptoms while helping to prevent an attack even if they are on inhaled corticosteroid-containing maintenance therapy.”¹

Findings from the pivotal phase 3 MANDALA and DENALI clinical trials were the foundation for the FDA’s approval in 2023. In MANDALA, albuterol/budesonide significantly reduced the risk of severe exacerbations compared use of albuterol monotherapy in patients with moderate to severe asthma when used as an as-needed rescue medication.² Importantly, the combination treatment was associated with a significant reduction in mean annualized total systemic corticosteroid exposure compared to albuterol alone.²

In the DENALI trial, albuterol/budesonide significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.²

The price of albuterol/budesonide to individuals with asthma is not available but AstraZeneca has announced a copay assistance program that for eligible commercially insured patients may reduce the cost to $0.⁵ According to reporting by Formulary Watch, Airsupra is now covered on the national formularies of the 3 largest commercial pharmacy benefit managers: Express Scripts, CVS Caremark, and Optum/United Healthcare.⁵

References

1. Airsupra (albuterol/budesonide) now available as the first and only FDA-approved anti-inflammatory rescue option for asthma. News release. AstraZeneca. January 22, 2024. Accessed February 1, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/airsupra-albuterol-budesonide-now-available-as-the-first-and-only-fda-approved-anti-inflammatory-rescue-option-for-asthma.html

2. FDA approves drug combination treatment for adults with asthma. News release. US Food and Drug Administration. News release. January 11, 2023. Accessed February 2, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma

3. Airsupra (PT027) approved in the US for asthma. Press release. AstraZeneca. January 11, 2023. Accessed February 1, 2024. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html

4. Global Initiative for Asthma. Global strategy for asthma management and prevention. 2023 update. Updated May 2023. Accessed February 1, 2024. www.ginasthma.org

5. Asthma rescue medication Airsupra is now available. Formulary Watch. January 22, 2024. Accessed February 2, 2024.

https://www.formularywatch.com/view/asthma-rescue-medication-airsupra-is-now-available