Bayer’s Finerenone (Kerendia®) Approved in the EU for Chronic Kidney Disease in Adults with Type 2 Diabetes
Feb 21, 2022 16:39
CST Updated
16:39
Bayer
Pharmaceutical Product R&D Developer
On February 21, 2022, Bayer announced that the European Commission had approved the marketing application for finerenone (Kerendia®), a non-steroidal, selective mineralocorticoid receptor antagonist, in 10mg and 20mg doses for the treatment of chronic kidney disease (stages 3 and 4 with albuminuria) in adult patients with type 2 diabetes.
"Even when blood sugar and blood pressure are well-controlled, the risk of chronic kidney disease progression and cardiovascular events in these patients remains high," said Professor Peter Rossing of the Steno Diabetes Center Copenhagen. "Since most patients do not exhibit symptoms in the early stages, individuals with type 2 diabetes should begin regular kidney monitoring early under the guidance of their doctor. Finerenone is the first non-steroidal, selective mineralocorticoid receptor antagonist approved for chronic kidney disease associated with type 2 diabetes. It targets key factors in disease progression that current therapies do not address, aiming to protect patients' kidneys and prevent further damage."
Finerenone is different from existing therapies for chronic kidney disease with type 2 diabetes. Finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, works by blocking the overactivation of mineralocorticoid receptors, a process considered to be associated with the progression of chronic kidney disease and cardiovascular damage. Preclinical studies have shown that finerenone can block the harmful effects caused by the overactivation of mineralocorticoid receptors. In patients with diabetes, overactivation of mineralocorticoid receptors is believed to lead to the progression of chronic kidney disease and cardiovascular damage, potentially driven by factors such as metabolism, hemodynamics, inflammation, and fibrosis.
Chronic kidney disease (CKD) is the most common complication in patients with diabetes and is also an independent risk factor for cardiovascular disease. Approximately 40% of patients with type 2 diabetes will progress to chronic kidney disease. Even with guideline-directed treatment, patients with chronic kidney disease and type 2 diabetes remain at high risk for CKD progression and cardiovascular events.
Bayer AG's Chief Medical Officer and Head of Medical Affairs & Pharmacovigilance, Dr. Michael Devoy, said: "The current situation is concerning, as chronic kidney disease in patients with type 2 diabetes is a leading cause of end-stage renal disease. These patients' kidneys eventually fail to meet the body’s demands, necessitating dialysis or a kidney transplant for survival. Early intervention leads to better outcomes, with the key being the prevention of further end-organ damage by reducing the risk of kidney function loss. The approval and launch of finerenone provide physicians with a new approach to protect these vulnerable patients by lowering cardiovascular event risks and slowing the progression of kidney disease."
The approval of finerenone in the EU was based on the results of the Phase III clinical FIDELIO-DKD study, which were presented at the 2020 American Society of Nephrology (ASN) Kidney Week and simultaneously published in The New England Journal of Medicine.
FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III clinical trial. It is the first large-scale study conducted in patients with CKD and T2D that designed the primary composite endpoint for renal outcomes and obtained positive results.
The study results showed that finerenone reduced the risk of the primary endpoint events, with consistent outcomes across all predefined subgroups, and the treatment effect was maintained throughout the study period. Compared with placebo, finerenone also significantly reduced the risk of key secondary endpoints, decreasing the composite risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median follow-up of 2.6 years. Patients in both groups received standard treatment, including glucose-lowering therapies and maximum tolerated doses of RAS blockade treatments such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
In July 2021, based on the positive results of the FIDELIO-DKD Phase III clinical study, finerenone received approval from the U.S. FDA. In December 2021, finerenone was granted an A-level recommendation in the American Diabetes Association (ADA) new treatment guidelines "Standards of Medical Care in Diabetes—2022" for patients with chronic kidney disease and type 2 diabetes who are at increased risk of cardiovascular events or chronic kidney disease progression, or for patients unable to use sodium-glucose cotransporter 2 inhibitors.
It is reported that Bayer has submitted the marketing application for finerenone in multiple countries/regions, and they are currently under review.
"Even when blood sugar and blood pressure are well-controlled, the risk of chronic kidney disease progression and cardiovascular events in these patients remains high," said Professor Peter Rossing of the Steno Diabetes Center Copenhagen. "Since most patients do not exhibit symptoms in the early stages, individuals with type 2 diabetes should begin regular kidney monitoring early under the guidance of their doctor. Finerenone is the first non-steroidal, selective mineralocorticoid receptor antagonist approved for chronic kidney disease associated with type 2 diabetes. It targets key factors in disease progression that current therapies do not address, aiming to protect patients' kidneys and prevent further damage."
Finerenone is different from existing therapies for chronic kidney disease with type 2 diabetes. Finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, works by blocking the overactivation of mineralocorticoid receptors, a process considered to be associated with the progression of chronic kidney disease and cardiovascular damage. Preclinical studies have shown that finerenone can block the harmful effects caused by the overactivation of mineralocorticoid receptors. In patients with diabetes, overactivation of mineralocorticoid receptors is believed to lead to the progression of chronic kidney disease and cardiovascular damage, potentially driven by factors such as metabolism, hemodynamics, inflammation, and fibrosis.
Chronic kidney disease (CKD) is the most common complication in patients with diabetes and is also an independent risk factor for cardiovascular disease. Approximately 40% of patients with type 2 diabetes will progress to chronic kidney disease. Even with guideline-directed treatment, patients with chronic kidney disease and type 2 diabetes remain at high risk for CKD progression and cardiovascular events.
Bayer AG's Chief Medical Officer and Head of Medical Affairs & Pharmacovigilance, Dr. Michael Devoy, said: "The current situation is concerning, as chronic kidney disease in patients with type 2 diabetes is a leading cause of end-stage renal disease. These patients' kidneys eventually fail to meet the body’s demands, necessitating dialysis or a kidney transplant for survival. Early intervention leads to better outcomes, with the key being the prevention of further end-organ damage by reducing the risk of kidney function loss. The approval and launch of finerenone provide physicians with a new approach to protect these vulnerable patients by lowering cardiovascular event risks and slowing the progression of kidney disease."
The approval of finerenone in the EU was based on the results of the Phase III clinical FIDELIO-DKD study, which were presented at the 2020 American Society of Nephrology (ASN) Kidney Week and simultaneously published in The New England Journal of Medicine.
FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III clinical trial. It is the first large-scale study conducted in patients with CKD and T2D that designed the primary composite endpoint for renal outcomes and obtained positive results.
The study results showed that finerenone reduced the risk of the primary endpoint events, with consistent outcomes across all predefined subgroups, and the treatment effect was maintained throughout the study period. Compared with placebo, finerenone also significantly reduced the risk of key secondary endpoints, decreasing the composite risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median follow-up of 2.6 years. Patients in both groups received standard treatment, including glucose-lowering therapies and maximum tolerated doses of RAS blockade treatments such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
In July 2021, based on the positive results of the FIDELIO-DKD Phase III clinical study, finerenone received approval from the U.S. FDA. In December 2021, finerenone was granted an A-level recommendation in the American Diabetes Association (ADA) new treatment guidelines "Standards of Medical Care in Diabetes—2022" for patients with chronic kidney disease and type 2 diabetes who are at increased risk of cardiovascular events or chronic kidney disease progression, or for patients unable to use sodium-glucose cotransporter 2 inhibitors.
It is reported that Bayer has submitted the marketing application for finerenone in multiple countries/regions, and they are currently under review.