SYMBICORT (budesonide/formoterol) TURBOHALER 200/6 APPROVED AS FIRST AND ONLY COMBINATION RELIEVER FOR MILD ASTHMA IN THE UK

• Symbicort Turbohaler 200/6 is the first and only approved dual-combination, inhaled corticosteroid + long-acting beta2-agonist (ICS/LABA) reliever therapy (Symbicort Reliever Therapy) to be taken as needed, in response to symptoms in patients with mild asthma aged 12 years and older.0F^[1],1F^[2],2F^[3]
• The approval by the Medicines and Healthcare products Regulatory Agency (MHRA) was based on positive results from four clinical trials which evaluated the efficacy of Symbicort Reliever Therapy compared with standard of care (SoC) therapies in mild asthma.^1,2,3F^[4],4F^[5]
• All patients with asthma are at risk of asthma attacks, including patients with mild asthma.5F^[6] Asthma outcomes are suboptimal in the UK with death and hospitalisation rates among the worst in Europe.6F^[7]
• It is widely accepted that an over-reliance on short-acting beta2-agonist (SABA) reliever inhalers is associated with an increased risk of asthma attacks, and contributes to the observed poor health outcomes in the UK.7F^[8],8F^[9]

London, UK, Thursday 23 March 2023 – AstraZeneca today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Symbicort (budesonide/formoterol) Turbohaler 200/6 in the United Kingdom as reliever therapy for adults and adolescents (12 years and older) with mild asthma.³ It is already approved in the UK for patients with moderate to severe asthma as Maintenance and Reliever Therapy (MART), and as maintenance therapy only.³

Budesonide/formoterol 200/6 is the first and only dual-combination (ICS/LABA) treatment to be approved in the UK for mild asthma, where a high unmet clinical need exists.^1,2 Evidence shows that patients with mild asthma remain at risk of severe asthma attacks, often associated with frequent over-reliance on short-acting beta2-agonist (SABA) inhalers.⁸ SABAs do not address underlying airway inflammation and for safety reasons are no longer recommended for use as monotherapy.⁸

This approval is based on positive data from clinical trials in more than 9,500 patients published in The New England Journal of Medicine and The Lancet, and forms a robust body of evidence demonstrating the effectiveness of budesonide/formoterol 200/6 compared with standard of care (SoC) therapies in mild asthma.^1,2,4,5

Asthma is a chronic, variable, inflammatory disease characterised by asthma attacks and symptoms including breathlessness and wheezing.9F^[10] In the UK it affects an estimated 8 million people.10F^[11] Deaths from asthma have increased by more than 26% in the last ten years.11F^[12] AstraZeneca estimates that approximately 2.65 million adults in the UK who live with mild asthma could be eligible for this treatment.12F^[13]

Professor Ian Pavord, Professor of Respiratory Medicine at the University of Oxford said: “In the UK, asthma attacks remain a major burden in patients diagnosed with mild asthma and these are driven by airway inflammation. Budesonide/formoterol 200/6 reliever therapy helps target airway inflammation and also delivers rapid, long-acting relaxation of the airway. I’m excited by the MHRA’s approval based on data from four key clinical trials which could potentially help address the unmet need for patients living with mild asthma in the UK.”

Ed Piper, Medical & Scientific Affairs Director, AstraZeneca UK, said: “We are delighted that the MHRA is the first regulatory agency in Europe to approve budesonide/formoterol 200/6 for use as a reliever in patients with mild asthma. This approval recognises the clinical utility of budesonide/formoterol 200/6 as an important new treatment option for patients with mild asthma in the UK.”

The safety and tolerability data for budesonide/formoterol 200/6 as needed in mild asthma were consistent with the known profile of the medicine.^1,2,4,5

AstraZeneca is committed to improving asthma care for patients in the UK. We are working towards a zero-tolerance approach to asthma attacks in the UK and are committed to reducing asthma-related exacerbations in a sustainable way that benefits both the patient community and the environment alike.

[1] Beasley R, Holliday M, Reddel HK, et al. Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma. N England Journal of Medicine. 2019;380(21):2020-2030.

[2] Hardy J, Baggott C, Fingleton J, et al. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial [published correction appears in Lancet. 2020 May 2;395(10234):1422]. Lancet. 2019;394(10202):919-928.

[3] Electronic Medicines Compendium (EMC). Symbicort 200mg/6mg Inhalation powder – Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1327/smpc#gref. Last accessed: March 2023.

[4] O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide-formoterol as needed in mild asthma. New England Journal of Medicine. 2018;378:1865-1876.

[5] Bateman ED, Reddel HK, O’Byrne PM, et al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma. New England Journal of Medicine. 2018;378:1877-1887.

[6] Asthma + Lung UK. What is Asthma. Available at: https://www.asthma.org.uk/conditions/asthma/what-asthma. Last accessed: March 2023

[7] Asthma + Lung UK. UK asthma death rates among worst in Europe. Available at: https://www.asthma.org.uk/about/media/news/press-release-uk-asthma-death-rates-among-worst-in-europe/. Last accessed: March 2023

[8] Kaplan A, Mitchell PD, Cave AJ, Gagnon R, Foran V, Ellis AK. Effective Asthma Management: Is It Time to Let the AIR out of SABA?. J Clin Med. 2020;9(4):921.

[9] Nwaru BI, Ekström M, Hasvold P, Wiklund F, Telg G, Janson C. 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.

[10] World Health Organisation. Asthma. Available at: https://www.who.int/news-room/facts-in-pictures/detail/asthma#:~:text=disease%20among%20children.,Asthma%20is%20a%20chronic%20disease%20characterized%20by%20recurrent%20attacks%20of,with%20chest%20tightness%20and%20cough. Last accessed: March 2023

[11] British Lung Foundation. Asthma statistics. Available at: https://statistics.blf.org.uk/asthma. Last accessed: March 2023.

[12] Asthma + Lung UK. Transforming asthma care in the UK. Available at: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiV-YTP0ur9AhUXhFwKHfedBzgQFnoECCsQAQ&url=https%3A%2F%2Fwww.asthmaandlung.org.uk%2Fsites%2Fdefault%2Ffiles%2FFighting%2520back_V3.pdf&usg=AOvVaw2nW5eXS5xsEjpnsM7MS45q. Last accessed: March 2023

[13] AstraZeneca. Data on file. REF-179537.