New data at ESC Congress 2021 showcase AstraZeneca’s leading cardiovascular, renal and metabolic portfolio

Farxiga chronic kidney disease, heart failure data and Brilinta ALETHEIA late-breaker among key congress highlights

2021 ESC Guidelines set to overhaul heart failure management

Advances in data science to optimise identification of cardiovascular events in clinical trials

AstraZeneca is sharing robust data across its cardiovascular, renal and metabolic (CVRM) portfolio at ESC Congress 2021 organised annually by the European Society of Cardiology (ESC), 27-30 August 2021. In total, 19 abstracts, including eight oral presentations, will be shared.

Key presentations include data from the DAPA-CKD and DAPA-HF Phase III trials demonstrating the beneficial effects of Farxiga (dapagliflozin) on kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) and heart failure (HF), two interrelated diseases with devastating impact for patients. Results from the ALETHEIA study will also be shared, investigating Brilinta (ticagrelor) 60 mg in routine clinical practice in the chronic setting among patients with a history of heart attack.

Joris Silon, Senior Vice President, CVRM, BioPharmaceuticals Business Unit, said: “Our bold ambition is to stop, reverse and cure cardiovascular, renal and metabolic diseases by maximising our medicines, delivering innovative solutions and advancing our pipeline. Key data at ESC Congress will demonstrate new scientific insights for important medicines including Farxiga and Brilinta, in addition to how we are harnessing data and technology to optimise and speed drug development and delivery. As we head into the congress, we look forward to the highly anticipated updated ESC Guidelines for the treatment and management of acute and chronic heart failure to be released.”

An evaluation of machine learning to automate clinical event identification against human expert adjudication in clinical trials will also be presented.

AstraZeneca presentations at ESC Congress 2021

Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 inhibitor. Research has shown Farxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas.^1-3 Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including type-2 diabetes (T2D), HF and CKD.^4-6

Farxiga is approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and in T2D to reduce the risk of hospitalisation for HF or CV death when added to standard of care based on the findings of the DECLARE-TIMI 58 Phase III CV outcomes trial.² Farxiga is also approved for the treatment of HF with reduced ejection fraction and the treatment of CKD based on the findings of the DAPA-HF and DAPA-CKD Phase III trials.^1,3

DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of Farxiga. It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience. Farxiga is currently being tested in the DELIVER Phase III trial to evaluate its efficacy in the treatment of patients with HF with preserved ejection fraction with or without T2D and in the DAPA-MI Phase III trial - a first of its kind, indication-seeking registry-based randomised controlled trial in patients without T2D following an acute myocardial infarction (MI) or heart attack.

Brilinta
Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y₁₂ receptor antagonist that works by inhibiting platelet activation. Brilinta, together with aspirin, has been shown to significantly reduce the risk of major adverse CV events (heart attack, stroke or CV death), in patients with acute coronary syndrome or a history of heart attack.^7,8 In the US, Brilinta is also indicated for the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease,⁹ and for the reduction of subsequent stroke in patients who experienced an acute ischaemic stroke or transient ischaemic attack.¹⁰

AstraZeneca in CVRM
CVRM, part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation 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. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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References

1.     Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446.
2.     Wiviott SD, et al. for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type-2 diabetes [article and supplementary appendix]. N Engl J Med. 2019;380:347-357.
3.     McMurray J, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019; 381:1995-2008.
4.     Mayo Clinic [Internet]. Heart failure, 2020; [cited 2021 Aug 10]. Available from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
5.       Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States, 2020; [cited 2021 Aug 10]. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.
6.     National Institute of Diabetes and Digestive And Kidney Diseases (NIH) [Internet]. Heart disease & kidney disease, 2016; [cited 2021 Aug 10]. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease.
7.    Brilinta^® (ticagrelor) tablets product information. AstraZeneca Pharmaceuticals LP; Wilmington, Delaware, USA. 2016.
8.    Kowalczyk M, et al. Ticagrelor – a new platelet aggregation inhibitor in patients with acute coronary yndromes. An improvement of other inhibitors? Med Sci Monit. 2009;15:MS24-30.
9.    Bhatt D.L et al. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): A phase 3, placebo-controlled, randomised trial. Lancet. 2019; 394:1169-1180.
10.  Johnston SC, et al. Ticagrelor and aspirin or aspirin alone in acute ischemic stroke or TIA. N Engl J Med. 2020; 383:207-217.

Veeva ID: Z4-36587
Date of Preparation: August 2021