Berlin, June 3, 2022, – Bayer will present new renal and cardiovascular data from the comprehensive Kerendia™ (finerenone) clinical trial program at the 2022 American Diabetes Association (ADA) 82nd Scientific Sessions. This new data will comprise of further insights from FIDELITY, including late-breaking data from a new post-hoc analysis, as well as retrospective findings from FIDELIO-DKD and FIGARO-DKD. 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 more than 13,000 patients with CKD and T2D.
Kerendia FIDELITY study data:
Data from a new post-hoc analysis from FIDELITY will investigate the effect of finerenone by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Despite well-controlled blood glucose levels and blood pressure, many patients with CKD and diabetes still progress to loss of kidney function. New strategies are needed to prevent further end-organ damage and slow patient’s rate of decline in kidney function.
· Effects of Finerenone in Patients with CKD and T2D Are Independent of HbA1c at Baseline, HbA1c Variability, and Duration of Diabetes
o 16-LB – Late Breaking Poster Session
o June 5, 2022; 12:00 – 1:00pm (CT) / 7:00 – 8:00pm (CEST)
In addition, a new subgroup analysis of FIDELITY will be presented, evaluating the effects of finerenone on kidney and cardiovascular (CV) outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline. This analysis encompasses a larger population including patients with earlier stages of CKD than was included in the previously presented subgroup analysis by GLP-1RA use from the FIDELIO-DKD trial.
· Finerenone in Patients across the Spectrum of CKD and T2D by GLP-1RA Use
o 22-OR – Oral Presentation
o June 3, 2022; 5:30 – 5:45pm (CT) / June 4, 2022; 12:30 – 12:45am (CEST)
Finerenone FIDELIO-DKD & FIGARO-DKD study data:
Bayer will present new exploratory data from FIDELIO-DKD and FIGARO-DKD, investigating the effects of finerenone on the development of vision-threatening complications in patients with diabetic retinopathy (DR).
· Effect of Finerenone on Occurrence of Vision-Threatening Events in Patients with DR
o 826-P – General Poster Session
o June 5, 2022; 12:00 – 1:00pm (CT) / 7:00 – 8:00pm (CEST)
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.
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 the 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.
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.