AstraZeneca announces two new Phase IIIb trials for Forxiga in chronic kidney disease and chronic heart failure

First programme to assess potential cardiovascular and renal benefit
of an SGLT-2i beyond diabetes

12 September 2016

AstraZeneca today announced two new randomised, placebo-controlled Phase IIIb outcome trials with Forxiga (dapagliflozin), an SGLT-2 inhibitor currently indicated for the treatment of type-2 diabetes. These two large outcome trials will help to define the potential role of dapagliflozin in the management of chronic kidney disease and chronic heart failure respectively, in people with and without type-2 diabetes.

This marks the first time a major outcome trial will be conducted to evaluate the effect of an SGLT-2 inhibitor in chronic kidney disease, for which there are currently few treatment options and a significant unmet medical need.^1,2

AstraZeneca today also announced the initiation of a series of new mechanistic trials designed to understand the underlying science behind the potential cardiovascular and renal protective signals seen with the SGLT-2 inhibitor class.

These new trials reinforce AstraZeneca’s commitment to Cardiovascular and Metabolic disease (CVMD) as one of its main therapy areas and to dapagliflozin, for which the body of evidence continues to grow with more than 80 completed and ongoing clinical trials and more than a million patients treated to date.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: “Our transformative clinical research aims to address the multiple risk factors associated with cardiovascular morbidity and mortality, including diabetes, chronic heart failure and chronic kidney disease. By following the science, we are seeking to improve outcomes for millions of patients with cardiovascular disease around the world.”

Professor John McMurray, Professor of Cardiology at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, and a member of the Executive Committee for both the chronic heart failure and chronic kidney disease trials, said: “This partnership between AstraZeneca and the wider clinical community is of great importance in allowing us to investigate the potential benefits of dapagliflozin in chronic heart failure and chronic kidney disease, and potentially to transform the way we view and manage these two conditions which place such a burden on our patients and health care systems.”

There are currently an estimated 200 million people worldwide currently living with chronic kidney disease,^[1] and 38 million people living with chronic heart failure.^[2]

NOTES TO EDITORS

About SGLT-2 inhibitors
Dapagliflozin (marketed as Farxiga in the US and Forxiga outside the US) is part of a class of medicines called sodium-glucose cotransporter 2 (SGLT-2) inhibitors used to manage type-2 diabetes, which remove glucose via the kidneys.

About AstraZeneca in Cardiovascular and Metabolic Disease (CVMD)
Cardiovascular, renal and metabolic diseases are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. By collaborating across therapeutic disciplines as part of the CVMD therapy area, we are addressing the multiple risk factors associated with CVMD, with the goal of reducing morbidity, mortality and organ damage through innovative therapies. Recognising the growing unmet need and challenges faced by the millions of people across the world living with these interrelated diseases, we’re determined to understand how they interact and impact one another – and how they can be treated together to save more patients’ lives.

About AstraZeneca
AstraZeneca 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 – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

References

^[i] Ojo A. “Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translation Research.” Transactions of the American Clinical And Climatological Association. 2014; 125:229-246.

^[ii] Eugene Braunwald. The war against heart failure: the Lancet lecture. The Lancet. 2015; 385: 812–24.