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
APPROVED USE
AIRSUPRA combines 2 medicines to be used as needed as a rescue inhaler in people 18 years of age and older to:
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 medicine13-15; 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
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