Bayer applies in EU for extension of Indication to Finerenone
The submission is based on positive data from the FIGARO-DKD study, which demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D.
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Berlin: Bayer has submitted a Type II Variation application to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorization to include early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
The submission is based on positive data from the FIGARO-DKD study, which demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine. FIDELIO-DKD and FIGARO-DKD are part of the largest Phase III clinical trial program to date in CKD and T2D which demonstrated positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease associated with type 2 diabetes.
"Many patients with chronic kidney disease and type 2 diabetes are progressing to kidney failure or premature death. Early diagnosis and treatment are important to reduce the high burden of cardiovascular and kidney events in these patients," said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. "The FIGARO-DKD study included patients with early stages of chronic kidney disease and demonstrated cardiovascular benefits of finerenone across a wide range of disease severity."
Based on the positive results of the FIDELIO-DKD Phase III study, in February 2022, finerenone was approved in the EU for adult patients with chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes. In July 2021, finerenone was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review.
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