Farxiga Phase III DAPA-CKD trial paradigm-shifting data to be presented at ESC 2020

Farxiga shows significant benefit across all primary and secondary endpoints in patients with chronic kidney disease with and without type-2 diabetes

Additional data from AstraZeneca’s broad portfolio reinforce the potential of its medicines to treat cardiovascular and renal diseases

27 August 2020

AstraZeneca will present the highly anticipated detailed results from the ground-breaking Phase III DAPA-CKD trial of Farxiga in chronic kidney disease (CKD) at ESC Congress 2020 – The Digital Experience.

These results are among 20 abstracts being presented by AstraZeneca at ESC between 29 August to 1 September 2020 showcasing the breadth of its cardiovascular (CV), renal and metabolic portfolio.

In July 2020, the Company announced that the DAPA-CKD trial met all primary and secondary endpoints in patients with CKD. High-level results showed a statistically significant and clinically meaningful effect with Farxiga on the trial’s primary endpoint of a composite of worsening of renal function or risk of death in CKD patients with and without type-2 diabetes (T2D).¹ The results also make Farxiga the first medicine to significantly reduce the risk of death from any cause in this patient population compared to placebo.¹

DAPA-CKD is yet another landmark trial from AstraZeneca’s global DapaCare clinical programme, which is dedicated to exploring the potential of Farxiga to protect against CV and renal disease.²

The programme first shared results from the DECLARE-TIMI 58 trial, the largest CV outcomes trial conducted for an SGLT2 inhibitor to date, showing that Farxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death versus placebo.³ The Phase III DAPA-HF trial results followed DECLARE, showing that Farxiga was the first SGLT2 inhibitor to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) with and without T2D.²

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The remarkable DAPA-CKD results which will be shared at this year’s ESC Congress bring us closer to transforming the management of chronic kidney disease, a condition associated with significant patient morbidity. These data, along with the wealth of new insights being presented across our wider portfolio, show our relentless dedication to advancing science across cardiovascular, metabolic and renal diseases.”

Key highlights at ESC Congress 2020 include:

• A pre-specified analysis of the DECLARE-TIMI 58 trial evaluating the relationship between baseline systolic blood pressure and the efficacy and safety of Farxiga on hHF and renal events in patients with T2D.⁴
• New sub-analyses from DAPA-HF reviewing the effect of Farxiga across the spectrum of baseline risk in heart failure (HF) and its impact on reducing the risk of hyperkalaemia in patients with HFrEF.^5,6
• Real-world evidence [from the UK] investigating the relationship between serum potassium variability or the duration of HF and the risk of hyperkalaemia and adverse clinical outcomes (all-cause mortality and major adverse CV events).^7,8
• New sub-analyses from the THEMIS trial including an oral presentation on peripheral artery disease (PAD) outcomes, on estimating the cost-effectiveness of Brilinta in patients who had a history of percutaneous coronary intervention (PCI), plus real-world evidence for THEMIS-like patients with T2D and coronary artery disease without prior myocardial infarction or stroke.^9-11
• Early science research on an epigenetic circuit linking oxidative stress and DNA hydroxymethylation in patients with HF.¹¹

AstraZeneca abstracts at ESC Congress 2020 – The Digital Experience:

All ESC Congress 2020 abstracts are available via the Scientific Programme & Planner.

AstraZeneca in CVRM

Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy 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 to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling comorbidities. 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 cardiovascular health for millions of patients worldwide.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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.