17
May
2022
|
09:00 AM
Europe/Amsterdam

Bayer to present new Kerendia™ (finerenone) data from comprehensive clinical trial program in chronic kidney disease and type 2 diabetes

Summary

New subgroup analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will reveal further insights into the efficacy and safety of Kerendia™ (finerenone) in patients with stage 4 chronic kidney disease (CKD) and type 2 diabetes (T2D) / Additional data from FIDELITY post hoc analysis will provide new insights comparing finerenone with spironolactone ± patiromer concerning blood pressure impact and safety / New comparison data between FIDELIO-DKD and CREDENCE will be presented, evaluating the effect of finerenone and canagliflozin in patients with CKD and T2D

Not intended for U.S. and UK Media - 59th ERA Congress Paris & Virtual 2022:

Berlin, May 17, 2022, - Bayer will present new renal and cardiovascular data from the comprehensive Kerendia™ (finerenone) clinical trial program at the 59th European Renal Association (ERA) congress 2022. This new data will include further insights from the FIDELITY prespecified pooled analysis, as well as new findings comparing finerenone outcomes from FIDELIO-DKD with outcomes from CREDENCE. 

To view the complete abstracts, please visit the ERA Congress Website, and download the Abstract Book.

Kerendia FIDELITY study data:

A new subgroup analysis from FIDELITY will be presented at the 59th ERA congress, investigating the efficacy and safety of finerenone in patients with stage 4 CKD and T2D compared to patients with stage 1-3 CKD and T2D:

· Outcomes with Finerenone in Patients with Stage 4 Chronic Kidney Disease and Type 2 Diabetes: A Fidelity Subgroup Analysis
o MO198 - Mini-Oral Session Clinical Nephrology
o May 19, 2022; 08:00am CEST, Mini-Orals Hall
o Abstract is published online in Nephrology Dialysis Transplantation, Volume 37, Issue Supplement_3, May 2022, gfac066.100, https://doi.org/10.1093/ndt/gfac066.100 

In addition, Bayer will showcase a new post hoc FIDELITY analysis, evaluating the effects of Kerendia, a non-steroidal, selective mineralocorticoid receptor antagonist, in comparison with the steroidal mineralocorticoid receptor antagonist spironolactone (AldactoneTM) ± potassium binding agent, patiromer (VeltassaTM) on serum potassium ([K+]) outcomes and discontinuations in a subgroup of patients that meet the eligibility criteria of the Phase II AMBER study. The AMBER study investigated the effects of spironolactone ± patiromer in 295 participants. 

· Finerenone in Resistant Hypertension in Moderate to Advanced CKD - A Post-Hoc Safety Analysis of FIDELITY
o MO1063 - Mini-Oral Session Clinical Nephrology
o May 19, 2022; 08:00am CEST, Mini-Orals Hall

The prespecified pooled analysis FIDELITY, including the Phase III studies FIDELIO-DKD and FIGARO-DKD, comprises the largest Phase III cardiorenal outcomes clinical trial program investigating cardiorenal outcomes in >13,000 patients with CKD and T2D. Results from FIDELITY were first presented at the European Society of Cardiology (ESC) congress 2021 and published in November 2021 in the European Heart Journal

Kerendia FIDELIO-DKD study data:

Bayer will present new matching-adjusted indirect comparison data of FIDELIO-DKD and the Phase III CREDENCE study. FIDELIO-DKD investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on renal and cardiovascular outcomes in approximately 5,700 patients with CKD and T2D. 

· Finerenone and Canagliflozin in the Treatment of Chronic Kidney Disease and Type 2 Diabetes: Matching-adjusted Indirect Treatment Comparison of FIDELIO-DKD and CREDENCE
o Free Communication Session FC083: Treatment for CKD - CKD - Pathophysiology, Epidemiology, Prevention, Progression, Ageing (11:45-13:15 CEST)
o May 21, 2022; 12:43 - 12:58 CEST; Virtual Hall 2
o The abstract is published online in Nephrology Dialysis Transplantation, Volume 37, Issue Supplement_3, May 2022, gfac115.003, https://doi.org/10.1093/ndt/gfac115.003

About Kerendia(finerenone)
Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. 

Based on the results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization in the European Union in February 2022 and was approved by the U.S. Food and Drug Administration (FDA) in July 2021. Based on the results of both pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD, Kerendia was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare (MHLW). Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review. 

The Phase III study program with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA, as well as the Phase II study CONFIDENCE.

About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes (T2D) develop CKD. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with T2D worldwide. CKD and T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and T2D are three times more likely to die from a cardiovascular-related cause than those with T2D alone.

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 driving sustainable development and generating 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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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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