Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis

AstraZeneca’s inhaled anti-inflammatory rescue medication AIRSUPRA demonstrated significant benefit compared to albuterol

Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ^® (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.¹ The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy.

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,² including over 25 million in the US.³ Patients with mild asthma comprise at least 50% of the US asthma population and are at risk of severe exacerbations.^4,5

James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and Chair, Independent Data Monitoring Committee, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time.”

Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca, said: “The impressive BATURA trial results add to the body of evidence supporting AIRSUPRA as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids.”

The safety and tolerability of AIRSUPRA in the BATURA trial was consistent with its established profile and no new safety concerns were reported. The data will be shared with health authorities and will be presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26 2024.

AIRSUPRA is the first and only anti-inflammatory rescue medication 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.⁶ The US approval was based on results from the MANDALA and DENALI Phase III trials.^7,8 AIRSUPRA is also being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial.^9,10 AIRSUPRA is being developed by AstraZeneca and Avillion.

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)

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

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,² including over 25 million in the US.³

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.¹¹ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^12,13 There are an estimated 136 million asthma exacerbations globally per year,¹⁴ including more than 10 million in the US;³ these are physically threatening and emotionally significant for many patients¹⁵ and can be fatal.^2,16

Inflammation is central to both asthma symptoms¹² and exacerbations.¹⁷ Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;^18-20 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,²¹ which can result in impaired quality of life,²² hospitalisation²³ and frequent oral corticosteroid (OCS) use.²³ 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.²⁴ International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.¹¹

BATURA

BATURA is a Phase IIIb, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed SABA alone, or as-needed SABA on a background of either low-dose ICS or LTRA maintenance therapy.²⁵

The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use.²⁵

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 pressurised metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology.⁶

Outside of the US, AIRSUPRA is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman.

AstraZeneca’s Collaboration with Avillion

In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre, clinical trial program for AIRSUPRA through NDA filing to a regulatory decision in the US. Following the successful approval of AIRSUPRA, AstraZeneca is commercializing the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of AIRSUPRA in reducing the risk of asthma exacerbations.

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

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 125 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.

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