Bayer to present new data on Kerendia™ (finerenone) from comprehensive clinical trial program in chronic kidney disease and type 2 diabetes
Not intended for U.S. and UK – Media 60th ERA Congress Milan & Virtual 2023:
Berlin, June 15, 2023 – Bayer will present new cardiorenal data from the comprehensive Kerendia™ (finerenone) clinical trial program in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at the 60th European Renal Association (ERA) congress 2023. This new data will include further insights from the FIDELITY prespecified pooled analysis on CKD progression, as well as new findings from the REKA and FINEGUST studies.
To view the complete abstracts, please visit the ERA Congress Website, and download the Abstract Book.
Kerendia FIDELITY study data:
A new post hoc analysis from FIDELITY will be presented at the 60th ERA congress, describing the validation of a previously developed lab-based risk prediction model, to accurately predict CKD progression in adults at all CKD stages. The post hoc analysis included all participants from the FIDELITY analysis, irrespective of estimated glomerular filtration rate (eGFR) or albuminuria stage.
· Validation of a CKD progression risk prediction model in the FIDELITY trial population
o June 16, 2023; 09:06am CEST, Focussed Oral Room 8
Kerendia FINEGUST study data:
Bayer will also be providing an update on the FINEGUST study (EUPAS48148; NCT05526157), which is a multinational observational cohort study and part of the FOUNTAIN multi-database research platform. FINEGUST aims to describe drug utilization and temporal changes of different treatments in adults with CKD and T2D in two time periods (before and after finerenone approval) using secondary data from population-based data sources in Europe, Japan, China, the United Kingdom, and the United States (US).
· Characteristics of medication-initiator cohorts of patients with chronic kidney disease and type 2 diabetes in Japan – a report from Fountain Platform
o June 17, 2023; 08:30am CEST, Focussed Oral Room 1
REKA US study data:
Bayer will present an evaluation of the occurrence of moderate to severe hyperkalemia (HK) episodes among a large, representative sample of patients with CKD from the US between 2009 and 2020. To date, reported numbers on the epidemiology of HK in patients diagnosed with CKD vary significantly and are unclear in real-world patients across different CKD stages, eGFR and UACR strata.
· Incidence and frequencies of hyperkalemia in patients with chronic kidney disease: a retrospective database study from US clinical care
o June 17, 2023; 15:05pm CEST, Focussed Oral Room 1
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 positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. In September 2022, Bayer announced that it received approval from the U.S. FDA for a label update for Kerendia™ to include findings from the Phase III FIGARO-DKD CV outcomes study. Based on the Phase III FIGARO-DKD findings, Kerendia™ received approval for a label extension from the European Commission in February 2023 and from the Chinese NMPA in May 2023, to include early stages of CKD associated with T2D. On the basis of both positive 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). Further regulatory approvals by other health authorities in multiple other countries have been granted or are currently pending following submissions for marketing authorization and label updates.
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.
Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, FIDELIO-DKD and FIGARO-DKD, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.
The prespecified FIDELITY pooled analysis, including the FIDELIO-DKD and FIGARO-DKD studies, investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D in reducing the risk of chronic kidney disease progression as well as fatal and nonfatal CV events and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes – KDIGO – risk categories) and the effects of finerenone on composite kidney and CV-specific endpoints.
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 develop chronic kidney disease. 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. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. 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.
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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 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.
New post hoc analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will validate a model predicting the risk of chronic kidney disease (CKD) progression in adults at all stages of CKD / Update on FINEGUST study, describing drug utilization and temporal changes of different treatments in adults with CKD and type 2 diabetes (T2D) both before and after finerenone approval / Evaluation of moderate to severe hyperkalemia occurrence among CKD patients between 2009 and 2020, in the REKA study