Bayer’s finerenone meets primary endpoint in Phase III FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes

Bayer’s finerenone meets primary endpoint in Phase III FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes

• Finerenone significantly reduced the composite primary endpoint of cardiovascular death or non-fatal cardiovascular events versus placebo when added to standard of care
• Following the FIDELIO-DKD study, FIGARO-DKD is the second positive Phase III study within the study program in chronic kidney disease (CKD) and type 2 diabetes (T2D) to meet its primary endpoint^1,2,3
• Patients with chronic kidney disease and type 2 diabetes are around three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone³
• Based on the comprehensive clinical trial program,^5,6,7 finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate renal and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes^3,5

Reading, 10 May, 2021 – Bayer’s Phase III study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug finerenone versus placebo when added to standard of care in patients with CKD and T2D[1] has met its primary endpoint, showing that it significantly reduced the composite risk of time to first occurrence of cardiovascular (CV) death or non-fatal CV events (myocardial infarction, stroke, or heart failure hospitalisation). The Phase III FIGARO-DKD study included more patients with earlier stage CKD and T2D compared to the FIDELIO-DKD study, which was the first of two Phase III studies investigating finerenone in patients with CKD and T2D.^1,2

“An estimated 160 million patients globally are living with chronic kidney disease and type 2 diabetes, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure.”^8,9,10 said Prof. Luis M. Ruilope, Professor at the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research Imas12, Madrid, Spain, and co-principal investigator of the FIGARO-DKD trial. “The FIGARO-DKD study delivers important insights into the cardiovascular benefits of finerenone, suggesting its potential to offer physicians a new tool in their armamentarium to protect these vulnerable patients by reducing their risk of cardiovascular events.” 

“Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart.^{3,11,12,13,14} With the positive outcome of the composite primary endpoint of the FIGARO-DKD trial, we have reached a significant milestone by completing the largest Phase III clinical trial program to date focusing on chronic kidney disease and type 2 diabetes across a broad range of disease severity,”^1,2 said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. "We are pleased to see that the FIGARO-DKD data further support the evidence generated in the FIDELIO-DKD trial⁷ with respect to reducing the combined risk of cardiovascular death or non-fatal cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes.”

The FIGARO-DKD study is part of the largest Phase III clinical trial program to date in CKD and T2D, which enrolled 13,000 patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease.^1,2 FIGARO-DKD is a randomised, double-blind, placebo-controlled, parallel-group, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D.^2,15 The study included approximately 7,400 patients from around 1,000 sites across 47 countries worldwide.^2,15 Patients were randomised to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of renin-angiotensin system (RAS)-blocking therapy such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).^2,15

The marketing authorisation application (MAA) submitted to the EMA, and the new drug application (NDA) accepted by U.S. FDA for Priority Review were based on positive data from the previously completed Phase III FIDELIO-DKD study and are currently under review. Results from this trial were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published online in the New England Journal of Medicine in October 2020.³ The clinical data from FIGARO-DKD will be presented at an upcoming scientific meeting.

Contact:

Dr. Daniela Esser, phone +49 30 468-15805

Email: daniela.esser@bayer.com

Veronica Yao, phone +44 (0) 7870 485 926

Email: veronica.yao.ext@bayer.com