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Kerendia™ (finerenone) receives expanded indication in the EU for the treatment of a broad range of patients with chronic kidney disease and type 2 diabetes

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Berlin, 10 February 2023 – The European Commission approved the extension of the label for Kerendia (finerenone) in the European Union (EU) to include cardiovascular (CV) outcome results from the Phase III Figaro-DKD study. The study showed that Kerendia reduced the risk of cardiovascular events in a broad range of patients with stages 1-4 CKD and T2D. Kerendia (10 mg or 20 mg) is a non-steroidal, selective mineralocorticoid receptor antagonist whose indication has been expanded to include early stages of CKD associated with T2D*. Kerendia is now indicated for the treatment of chronic kidney disease (with proteinuria) associated with type 2 diabetes in adults. The pivotal Phase III FigARO-DKD study results were presented at the European Society of Cardiology (ESC) Congress 2021 and published simultaneously in the New England Journal of Medicine. FIGARO-DKD investigated the efficacy and safety of ryanodone in reducing cardiovascular morbidity and mortality compared with placebo and standard of care in approximately 7,400 patients with CKD and T2D. Positive data from Figaro-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D compared to placebo.

“Patients with chronic kidney disease are at increased risk of cardiovascular events,” said Prof. Peter Rossing, Head of Complications Research at the Steno Diabetes Center in Copenhagen. “Because chronic kidney disease progresses slowly and is often asymptomatic in its early stages, patients with type 2 diabetes should be regularly monitored by their physicians for the earliest signs of kidney disease and, once diagnosed, should be treated comprehensively to reduce the risk of cardiovascular complications and death.”

Mineralocorticoid receptor (MR) overactivation leads to CKD progression and CV injury, which may be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Kerendia provides protection against the alternative pathway as it selectively binds to MR receptors, preventing the deleterious effects of MR overactivation.

“Even with well-controlled blood glucose levels and blood pressure, patients with chronic kidney disease and type 2 diabetes remain at high risk of kidney disease progression and cardiovascular events,” said Dr. Michael Devoy, Chief Medical Officer, Bayer Pharmaceuticals. “Kerendia addresses a key cause of disease progression unaddressed by other therapies and offers physicians a unique pathway to protect patients from further renal injury and cardiovascular events. Kerendia demonstrated renal and cardiovascular benefits across multiple disease severities in pivotal Phase III studies, and today’s approval of the label extension supports the drug’s use in patients with early-stage * chronic kidney disease associated with type 2 diabetes.”

Based on FIDELIO – Positive results from a Phase III study in DKD, with Kerendia receiving initial marketing authorization from the European Commission in February 2022 for the treatment of adults with T2D-related CKD (stages 3 and 4 with proteinuria). Following approval by the European Commission, Kerendia’s extended EU label now reflects data based on more than 13,000 patients with CKD and T2D from the Phase III FIDELIO-DKD and FigARO-DKD studies. About Kerendia™ (finerenone)

Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block the deleterious effects of MR overactivation. MR overactivation leads to CKD progression and cardiovascular injury, which may be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ received marketing authorization from the U.S. Food and Drug Administration (FDA) in July 2021, the European Commission (February 2022) and the National Medical Products Administration of China (NMPA) in June 2022. In September 2022, Bayer announced that it has received US FDA approval to update the label of Kerendia™ to include the results of the Phase III FIGARO-DK D CV results study. In February 2023, based on the results of the Phase III Figaro-DKD study, Kerendia™ received approval for a label extension from the European Commission to cover early stages of CKD associated with T2D. Based on positive results from two pivotal Phase III studies, FIDELIO-DKD and Figaro-DKD, Kerendia™ was approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) in March 2022. Further regulatory approvals have been obtained or are currently awaited by other health authorities in several other countries following submission of the Marketing Authorization.

The Phase III study program FINEOVATE for finerenone currently includes five Phase III studies: FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and FIONA, and the Phase II study CONFIDENCE.

The Phase III program of Finerenone in CKD and T2D randomized over 13,000 patients with CKD and T2D around the world and included two completed and published studies: FIDELIO-DKD and FigARO-DKD, which evaluated the impact of Finerenone versus placebo on renal and cardiovascular outcomes in addition to standard of care.

The prespecified FIDELITY pooled analysis (including the FIDELIO-DKD and FigARO-DKD studies) investigated the efficacy and safety of Finerenone in reducing the risk of chronic kidney disease progression and fatal and non-fatal cardiovascular events in patients with T2D CKD, and provided insight into CKD stage (based on baseline renal disease: improved global outcomes – KDIGO – risk category) versus Finerenone’s effect on composite cardiovascular Relationship between and kidney-specific endpoints. Chronic Kidney Disease in Type 2 Diabetes

Chronic kidney disease (CKD) is a common and potentially fatal condition that is widely underrecognized. The progression of chronic kidney disease is silent and unpredictable, with many symptoms not appearing until the disease is severely advanced. CKD is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease. Up to 40% of people with type 2 diabetes have chronic kidney disease. Despite guideline-directed therapy, patients with CKD and T2D remain at high risk for CKD progression and cardiovascular events. CKD is estimated to affect more than 190 million people with T2D worldwide. Chronic kidney disease in type 2 diabetes is the leading cause of end-stage renal disease, requiring dialysis or a kidney transplant to sustain life. Patients with Chronic Kidney Disease and Type 2 Diabetes were three times more likely to die from cardiovascular-related causes than those with Type 2 Diabetes alone. About Bayer’s commitment in the field of cardiovascular and kidney diseases

Bayer is an innovative leader in the field of cardiovascular diseases, and has long been committed to bringing a better life to mankind by advancing innovative treatment combinations. The heart and kidneys are closely linked in health and disease, and Bayer is working in a broad therapeutic area on new treatments for cardiovascular and kidney diseases, which have unmet medical needs. Bayer’s cardiology franchise already includes multiple products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s research approach, which prioritizes targets and pathways that have the potential to impact the way cardiovascular disease is treated. About Bayer

Bayer is a global company with core competencies in life sciences, including healthcare and nutrition. Its products and services are designed to help people and the planet thrive by supporting the major challenges posed by a growing and aging global population. Bayer is committed to promoting sustainable development and having a positive impact on its business. At the same time, the Group aims to increase profitability and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality all over the world. In fiscal year 2021, the group has about 100,000 employees and sales of 44.1 billion euros. Pre-Project R&D Expenses For more information, please visit

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This press release may contain forward-looking statements that are based on current assumptions and projections of Bayer management. Various known and unknown risks, uncertainties and other factors could cause the company’s actual future results, financial condition, development or performance to differ materially from the estimates given here. These factors include factors discussed in Bayer’s public reports, which can be found on the Bayer website at The company undertakes no duty to update these forward-looking statements or to conform them to future events or developments.

CKD stage 1-2, according to KDIGO classification, estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73m



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