AIRSUPRA (PT027) Approved in the US for Asthma

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WILMINGTON, DE — AIRSUPRA™ (albuterol/budesonide), formerly known as PT027, has been approved in the US 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, announced AstraZeneca.

The approval by the Food and Drug Administration (FDA) was based on results from the MANDALA and DENALI Phase III trials.1,2 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.1 Importantly, 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.1 In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.2

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 (ICS) in the US. It is being developed by AstraZeneca and Avillion.

Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: “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.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “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 AIRSUPRA, an important new rescue treatment that reduces the risk of asthma exacerbations.”

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Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide.3 In the US over 21 million adults have asthma, representing more than 80% of the total number of people with asthma.4 Adults have 8.5 million exacerbations each year in the US.4 Uncontrolled asthma will cost the US economy an estimated $300 billion (in 2018 dollar values) in the next 20 years in direct medical costs alone.5

The safety and tolerability of AIRSUPRA in both trials were consistent with the known profiles of the components,1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia.6

Results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.1

References

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  2. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med 2022; 205: A3414. Abstract. Available at: https://doi.org/10.1164/ajrccm-conference.2022.205.1_MeetingAbstracts.A3414 [Last accessed: November 2022].
  3. The Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/index.html [Last accessed: November 2022].
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  19. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900.
  20. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.
  21. Chipps BE, et al. Evaluation of the Efficacy and Safety of As-Needed PT027 Budesonide/Albuterol MDI) Compared to As-Needed Albuterol MDI in Adults and Children 4 Years of Age or Older with Uncontrolled Moderate to Severe Asthma: Design of the MANDALA Study. Am J Respir Crit Care Med. 2020; 201: A3015.
  22. Papi A, et al. Efficacy and safety of as-needed albuterol/budesonide versus as-needed albuterol in adults, adolescents and children aged ≥4 years with moderate-to-severe asthma: Results of the MANDALA study. American Thoracic Society International Conference 2022. Oral Presentation. Abstract A3413 during B93. BREAKTHROUGHS IN PEDIATRIC AND ADULT ASTHMA CLINICAL TRIALS.
  23. Clinicaltrials.gov. A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI). Available at https://clinicaltrials.gov/ct2/show/NCT03847896. [Last accessed: November 2022].
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