Astrazeneca - AIRSUPRA now available as the first and only FDA-approved anti-inflammatory rescue option for asthma

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.

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.

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