Bayer Inc. announced that Health Canada approved finerenone, under the brand name KERENDIA, as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease and a sustained decrease in estimated glomerular filtration rate, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure. Finerenone is available in two tablet strengths – 10 mg and 20 mg.
The approval of finerenone by Health Canada is based on the positive results of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies. FIDELIO-DKD was presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 2020 . FIGARO-DKD was presented at the European Society of Cardiology (ESC) Congress on August 28, 2021 and published in the New England Journal of Medicine in December 2021.
“There is an unmet need for patients with kidney disease from diabetes, it remains the number one cause of end stage kidney disease requiring dialysis in Canada and triples the risk of dying from cardiovascular disease over type 2 diabetes alone,” said Dr. Sheldon Tobe, University of Toronto Postgraduate Fellowship Director – Nephrology and Professor of Medicine, University of Toronto and Northern Ontario School of Medicine. “For patients with diabetic kidney disease across a wide range of severity, the addition of finerenone to standard of care produced a dramatic improvement in the risk of heart disease and the risk of loss of kidney function and the need for dialysis. For patients who develop diabetes today, I believe that finerenone together with our best therapies, has the potential to improve cardiovascular outcomes and prevent the need for dialysis over their lifetime.”
Chronic kidney disease is a common and potentially deadly condition that is generally underrecognized. CKD can shorten life expectancy of patients with type 2 diabetes by up to 16 years relative to the general population living without either disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. In T2D, mineralocorticoid receptor (MR) overactivation is thought to contribute to CKD progression which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors.
“FIDELIO-DKD is the first large contemporary Phase III positive outcomes study in patients with chronic kidney disease and type 2 diabetes with a primary composite endpoint consisting exclusively of kidney-specific outcomes, while FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage (1-2) CKD with albuminuria to show CV benefit in patients with CKD associated with T2D. These two trials are a part of the largest global Phase III clinical trial program to date in CKD and T2D,” said Dr. Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. “With our longstanding expertise in innovative science in the cardiovascular space, today’s approval of finerenone marks an important milestone in Bayer’s commitment to improving the lives of patients with kidney and cardiovascular diseases.”