Mississauga, ON, November 10, 2021 – New data analyses of the comprehensive finerenone clinical trial program, including the pivotal Phase III studies FIGARO-DKD² and FIDELIO-DKD1 and the pre-specified pooled analysis FIDELITY³ reinforce the renal and cardiovascular (CV) benefits of finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist^,1 in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Data from the analyses were presented at the American Society of Nephrology (ASN)’s Kidney Week 2021.

A new analysis of the FIGARO-DKD study data shows that in patients with CKD stages 1–4 with moderate-to-severely elevated albuminuria, it was seen that finerenone was associated with a trend towards reduced composite kidney outcomes which was generally consistent with the benefit seen in FIDELIO-DKD. Finerenone was also associated with a 36% lower incidence of end-stage kidney disease (ESKD). ESKD occurred in 0.9% of finerenone vs 1.3% of placebo recipients (HR=0.64; 95% CI 0.41-0.995; nominal p-value=0.046).² 

This follows the FIGARO-DKD detailed study results presented in September at the ESC Congress 2021 and simultaneously published in the New England Journal of Medicine, which confirmed the cardiovascular benefits of finerenone as demonstrated in the FIDELIO-DKD study, focusing on CKD and type 2 diabetes (T2D) across a broad range of disease severity, including patients with stages 1-4 CKD and T2D.

“More needs to be done to slow the progression of chronic kidney disease (CKD) secondary to type 2 diabetes (T2D). It is the most common cause of end-stage kidney disease (ESKD) worldwide,”^4,5 said Professor George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. “The results presented at ASN from FIDELIO-DKD and FIGARO-DKD, and specifically from the FIDELITY prespecified pooled analysis of these trials, clearly demonstrate the potential to improve outcomes in patients with CKD through timely detection and monitoring of the earliest signs of chronic kidney disease, and underscore finerenone as an effective treatment option to improve cardiovascular and kidney outcomes across a broad range of patients, including those with early kidney damage and more advanced stages of chronic kidney disease and type 2 diabetes.”^1,2 

Results from FIDELITY, a pre-specified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD2 and FIDELIO-DKD1 further demonstrated the renal and CV benefits of finerenone across the spectrum of CKD severity in patients with T2D.³ The results show that finerenone consistently reduced the risk of the kidney composite outcome (time to kidney failure, sustained ≥57% decrease in eGFR from baseline, or renal death) by 23% (HR=0.77; 95% CI 0.67–0.88; p=0.0002), and the risk of ESKD by 20% (HR=0.80; 95% CI 0.64–0.99; p=0.040).3 Overall safety was also shown to be similar between finerenone and placebo groups, with renal adverse events (AEs) balanced between treatment groups. An expected increase in hyperkalemia-related AEs was observed with finerenone but treatment discontinuation due as a result of hyperkalemia AEs was low.³

Additional data from the pre-specified pooled analysis FIDELITY showed that irrespective of SGLT2i use at baseline, finerenone demonstrated consistent kidney and CV benefits versus placebo, and reduced UACR in patients with CKD and T2D (32% vs 37%, respectively).³ 

In the prespecified pooled analysis FIDELITY, patients treated with an SGLT2i at baseline had higher mean eGFR, lower UACR and higher statin and GLP‑1RA use. The new analysis shows consistent kidney and CV benefits of finerenone versus placebo, and an improvement of UACR in patients with CKD and T2D, irrespective of baseline treatment with an SGLT-2i.³  

“The FIGARO and FIDELIO trials studied cardiorenal outcomes in people with diabetes and a spectrum of kidney disease from early to advanced. As an investigator in both trials, it was very satisfying to see how well finerenone reduced cardiovascular events and progression of kidney disease in this broad range of patients,’ said Dr. Phil McFarlane, clinical-investigator in the Division of Nephrology at St. Michael's Hospital in Toronto. “As a nephrologist, it was particularly exciting to see the rate of end-stage renal disease reduced in the recently presented FIGARO study. These studies usher in an era of next generation MR antagonist, and play an important role in the development of new treatment options for heart and kidney protection in people with diabetes.”

In July, finerenone was approved under the brand name Kerendia^® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO- DKD Phase III study. Finerenone has also been submitted for marketing authorization in Canada, the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review. Finerenone does not yet have marketing authorization in Canada.

About Finerenone
Finerenone (BAY 94-8862) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation.¹ In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors.^1,4,8,9,10 The Phase III study programme with finerenone, FINEOVATE, currently comprises four Phase III studies, FIDELIO-DKD1, FIGARO-DKD2, FINEARTS-HF11 and FIND-CKD.¹²

Having randomized more than 13,000 patients with CKD and T2D around the world, including Canada, the Phase III program with finerenone in CKD and T2D comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.13 FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. 1,14 FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D. 

In September 2021, Bayer announced the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone in patients with non-diabetic chronic kidney disease. FIND-CKD will investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.

In June 2020, Bayer announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure (New York Heart Association class II-IV) with preserved ejection fraction, i.e. a left ventricular ejection fraction of ≥40%. The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).

In July, finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study. Finerenone has also been submitted for marketing authorization in Canada, the European Union (EU) and China, as well as multiple other countries worldwide and these applications are currently under review.

About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a potentially deadly condition that is generally underrecognized.17 CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.5 Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.^4,5,18 Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events.^4,6,7 It is estimated that CKD affects more than 160 million people with T2D worldwide.^19.20,21 Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease,5 which requires dialysis or a kidney transplant to stay alive.²² Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.²³

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.ca.

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Forward-Looking Statements 
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

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3.    FIDELITY results placeholder
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