• Adults living with asthma now have an approved rescue treatment designed to treat both symptoms and inflammation to help prevent asthma attacks

WILMINGTON, Del. / Jan 22, 2024 / Business Wire / AstraZeneca announces AIRSUPRA^® (albuterol/budesonide), is now commercially available in the US by prescription. AIRSUPRA received FDA approval in January 2023 for the as-needed treatment or prevention of symptoms of asthma and to help prevent sudden severe breathing problems (asthma attacks) in people aged 18 years and older.¹

AIRSUPRA contains a short-acting beta₂-agonist (SABA), to help relax the smooth muscles of the airways, and an inhaled corticosteroid (ICS), to help decrease inflammation in the lungs.² AIRSUPRA was approved based on the results from two Phase III trials, MANDALA and DENALI. In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma. In DENALI, AIRSUPRA had a similar onset of bronchodilation compared to albuterol in patients with mild to moderate asthma.²

The approach to treating asthma symptoms with rescue has changed. The 2023 Global Initiative for Asthma (GINA) report supports a rescue approach that treats both symptoms and inflammation together. Combination SABA/ICS is now recommended as a rescue option for adults with asthma regardless of ICS maintenance medication.³ According to GINA, recommendations for a change in rescue approach were largely based on the risk associated with SABA-only treatment of asthma.³ AIRSUPRA is the only FDA-approved, as-needed SABA/ICS asthma rescue now available in the US and is designed to treat both symptoms and inflammation.^2,4

Priya Bansal MD, Physician and CEO, Asthma and Allergy Wellness Center said: “For over five decades, the medical community has used SABA-only rescue which does not address the inflammatory component of asthma. Now, with AIRSUPRA available we can provide patients, especially those on maintenance therapy, another rescue option for managing their breakthrough symptoms. 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 ICS-containing maintenance therapy.”

Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca said: “With AIRSUPRA now available in the US, we are taking an important step in our mission to revolutionize asthma for millions of people living with the disease. We are hopeful our innovative asthma rescue medicine can help alleviate the burden by addressing both symptoms and underlying inflammation simultaneously at the right time to reduce the risk of having a severe asthma attack.”

Those interested in receiving AIRSUPRA are encouraged to speak with a healthcare provider to determine if AIRSUPRA is an appropriate treatment option. AstraZeneca is offering a copay assistance program where eligible patients may pay as little as $0 for AIRSUPRA. To learn more, visit airsupra.com.

IMPORTANT SAFETY INFORMATION

• Do not use AIRSUPRA if you are allergic to albuterol, budesonide, or any of the ingredients in AIRSUPRA
• Before using AIRSUPRA, tell your healthcare provider about all your medical conditions and about all the medicines you take
• A dose of AIRSUPRA is 2 inhalations (puffs) as needed. Use AIRSUPRA exactly as your healthcare provider tells you to use it. Do not use AIRSUPRA more than 12 puffs (which equals 6 doses) within a 24-hour period
• AIRSUPRA is not to be used as a maintenance treatment for asthma. If you are currently taking medicine long-term to maintain control of asthma symptoms, you should continue to take that medicine as directed by your healthcare provider
• Do not change or stop other inhaled medicines or asthma medicines (oral or inhaled) without first talking to your healthcare provider
• Call your healthcare provider or get emergency medical care right away if your breathing problems get worse, you need to use AIRSUPRA more often than usual, or AIRSUPRA does not work as well to relieve your asthma
• AIRSUPRA can cause serious side effects, including:
  • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care right away. This is more likely to happen with your first use of a new canister of medicine
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people who use too much AIRSUPRA
  • serious allergic reactions. Tell your healthcare provider or get emergency medical care right away if you have a skin rash, redness, or swelling; severe itching; swelling of the face, mouth, or tongue; trouble breathing or swallowing; or chest pain
  • changes in laboratory blood levels. Low levels of potassium (hypokalemia) may cause abnormal heart rhythms
  • weakened immune system and increased chance of getting infections
  • fungal infection in your mouth and throat (thrush). This is a common side effect. Rinse your mouth with water, if available, without swallowing after using AIRSUPRA to help reduce your chance of getting thrush
  • reduced adrenal function (adrenal insufficiency). This can happen when you start taking a medicine containing an inhaled corticosteroid (such as AIRSUPRA)
  • bone thinning or weakness (osteoporosis)
  • eye problems, including glaucoma and cataracts. Your healthcare provider may suggest having regular eye exams while using AIRSUPRA. Discuss any eye problems with your healthcare provider
• Common side effects include headache, cough, and hoarseness. These are not all the side effects of AIRSUPRA. For more information, ask your healthcare provider or pharmacist

APPROVED USE

AIRSUPRA combines 2 medicines to be used as needed as a rescue inhaler in people 18 years of age and older to:

• treat or prevent symptoms of asthma
• help prevent sudden severe breathing problems (asthma attacks or exacerbations)

Please see full Prescribing Information and Patient Information and discuss with your doctor.

You may report side effects related to AstraZeneca products.

Notes

Asthma

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,⁵ including approximately 25 million in the US.⁶

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.³ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^7,8

There are an estimated 136 million asthma exacerbations globally per year,⁹ including approximately 10 million in the US⁶; these are physically threatening and emotionally significant for many patients¹¹ and can be fatal.^3,10

Inflammation is central to both asthma symptoms⁷ and exacerbations.¹² Many patients experiencing asthma symptoms use a SABA (eg, albuterol) as a rescue medicine^13-15; however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,¹⁶ which can result in impaired quality of life,¹⁷ hospitalization¹⁸ and frequent oral corticosteroid (OCS) use.¹⁸ Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.¹⁹ International recommendations from the GINA no longer recommend SABA alone as the preferred rescue therapy.³

AIRSUPRA

AIRSUPRA® (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology.

The FDA approval of AIRSUPRA was based on MANDALA and DENALI Phase III trials (Approval press release). 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. For patients treated with AIRSUPRA 180 mcg/160 mcg the annualized total systemic corticosteroids dose when compared with albuterol 180 mcg was statistically significantly different, with a reduction in mean annualized dose of 40 mg per patient. In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.

About AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

References

1. AstraZeneca. AIRSUPRA^® (PT027) approved in the US for asthma. [Press release]. Accessed: January 2024. https://www.astrazeneca-us.com/media/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html
2. AIRSUPRA^® (albuterol/budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2023.
3. Global Initiative for Asthma. Updated May 2023. Accessed: January 2024. www.ginasthma.org
4. US FDA. FDA approves drug combination treatment for adults with asthma. Accessed: January 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma
5. The Global Asthma Report 2022. Accessed: January 2024. http://globalasthmareport.org/index.html
6. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. Accessed: January 2024. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
7. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014;24:14009.
8. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018;6(6): 1989-1998.e3.
9. Data on File. REF-173201. AstraZeneca Pharmaceuticals LP.
10. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014;40(4):364-372.
11. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016;9:13.
12. Wark PA, et al. Asthma exacerbations . 3: Pathogenesis. Thorax. 2006;61(10):909-915.
13. Johnson DB, et al. Albuterol. In: StatPearls. Treasure Island (FL): StatPearls Publishing; November 17, 2023.
14. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care. November 2021, 66 (Suppl 10) 3603775.
15. ClinCalc.com. Albuterol Drug Usage Statistics, United States, 2013-2020. Accessed: January 2024. https://clincalc.com/DrugStats/Drugs/Albuterol
16. Nwaru BI, et al. Overuse of short-acting β₂-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020;55(4):1901872.
17. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007;16(1):22-27.
18. 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.
19. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018;11:193-204.