AIRSUPRA ® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma[...]

The US Food and Drug Administration (FDA) has approved a supplemental

new drug application (sNDA) for AIRSUPRA

AIRSUPRA's US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.¹ The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to as-needed albuterol,² the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% confidence interval [CI]: 0.40, 0.72; p<0.001) when compared with albuterol in adult patients with mild asthma.²

The inclusion of BATURA study results in the US prescribing information builds upon the previous MANDALA Phase III trial in adult patients with moderate to severe asthma.³ The MANDALA and BATURA clinical trials demonstrate the benefit of as-needed AIRSUPRA in reducing the risk of severe exacerbations across all asthma severities compared to albuterol.^2-3

In BATURA, AIRSUPRA demonstrated a significant reduction in the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% CI: 0.40, 0.72; p<0.001) when compared to albuterol in adult patients with mild asthma.² In addition to achieving the primary endpoint, a reduction in the annualized severe exacerbation rate and in annualized systemic steroid dose were also observed.² These positive results from BATURA were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2025 International Conference in San Francisco. Safety findings in the BATURA trial demonstrated the safety and tolerability of AIRSUPRA. Thus, AIRSUPRA was consistent with its established safety profile.²

The initial US approval of AIRSUPRA was based on results from the Phase III MANDALA trial and Phase III DENALI trial (lung function trial in patients with mild to moderate asthma), and now includes the addition of BATURA, a Phase IIIb trial in patients with mild asthma.^2-4

The Global Initiative for Asthma (GINA) has recommended against SABA-only treatment of asthma in adults since 2019.⁵ The 2025 Report from GINA supports an anti-inflammatory rescue approach in adults of all asthma severities.⁶ 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.^1,7

Dr. Reynold A. Panettieri Jr, Vice Chancellor and Professor of Medicine at Rutgers Institute for Translational Medicine and Science, said: "This label update approved by the FDA ensures that the critical evidence for AIRSUPRA in mild asthma is now included in the prescribing information, allowing physicians to make the most informed decisions about rescue medicine for their patients. This update, along with the recent GINA Report, supports an anti-inflammatory rescue approach for adults of all asthma severities."

Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca said: "Patients living with asthma deserve a treatment that offers more than just relief from their symptoms. With this label update for AIRSUPRA, which includes proven benefits for mild asthma, patients across all asthma severities have a superior choice for their asthma rescue medication."

AIRSUPRA was developed by AstraZeneca and Avillion.

APPROVED USE

AIRSUPRA combines two 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 (opens new window).

Notes

Asthma
Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, ⁸ including approximately 27 million in the US.⁹

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.⁶ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^10,11 There are an estimated 136 million asthma exacerbations globally per year,¹² including more than 11 million in the US,⁹ these are physically threatening and emotionally significant for many patients¹³ and can be fatal.^6,14

Inflammation is central to both asthma symptoms¹⁰ and exacerbations.¹⁵ Many patients experiencing asthma symptoms use a Short-Acting Beta Agonist (SABA) (eg albuterol) as a rescue medicine^16-18; however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,¹⁹ which can result in impaired quality of life,²⁰ hospitalization²⁰ and frequent oral corticosteroid (OCS) use.²⁰ 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.²¹ International recommendations from the Global Initiative for Asthma no longer recommend SABA-only treatment of asthma in adults.⁶

Phase IIIb BATURA trial
BATURA was a Phase IIIb, US-based, randomized, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of inhaled albuterol/budesonide (180 mcg/160 mcg) as an as-needed rescue medication in response to symptoms compared to as-needed inhaled albuterol (180 mcg) 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 only, or as-needed SABA with either low-dose inhaled corticosteroid (ICS) or leukotriene receptor antagonists (LTRA) maintenance therapy.²² While patients 12 to 17 years were included in BATURA, AIRSUPRA is not approved in this age group. AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

Participants (n=2421) were randomized and treated 1:1 with AIRSUPRA (n=1209) or albuterol as needed (n=1212) for 12-52 weeks. Two efficacy analysis populations were defined: the on-treatment population (data collected on-treatment before randomized treatment discontinuation or step-up maintenance therapy) and the intent-to-treat (ITT) population (all data, regardless of these events).²

The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included annualized severe exacerbation rate and annualized total systemic corticosteroid dose. A severe exacerbation was defined as a worsening of symptoms resulting in three or more days of SCS use, an emergency department visit, urgent care visit or hospitalization for asthma or death.²

BATURA was a first-ever decentralized, patient-centric design that allowed participants to accommodate trial-related activities around their daily lives and was intended to remove logistical barriers, thereby lowering participant burden and increasing efficiency and equitable access to the study.²³

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 pressurized metered-dose inhaler (pMDI) using AstraZeneca's Aerosphere delivery technology.

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, multicenter 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's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit https://www.astrazeneca-us.com and follow the Company on social media @AstraZeneca.

Media Inquiries

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References

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