On July 9, 2021, Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Kerendia (finerenone) to reduce the estimated persistent decline in glomerular filtration rate (eGFR) in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). Risk of end-stage renal disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure.
Kerendia (finerenone)
Kerendia (finerenone, Chinese name: feneridone) is a potential first-in-class non-steroidal, selective mineralocorticoid receptor antagonist (MRA), can reduce the mineralocorticoid receptor (MR) Harmful effects of hyperactivation. Mineralocorticoid receptor overactivation is a major driver of renal and cardiac damage. In 2015, the FDA granted finerenone Fast Track designation (FTD).
The FDA approval is based on positive results from a Phase III study codenamed FIDELIO-DKD (NCT02540993). The FIDELIO-DKD study was a randomized, double-blind, placebo-controlled study. A total of 5734 patients were recruited, and the subjects were randomized 1:1 into two groups to receive finerenone and placebo, respectively. The primary composite endpoint assessed in the time-event analysis was renal failure, a greater than 40% reduction from baseline in eGFR, or the number of deaths from renal causes. The key secondary composite endpoint assessed in the time-event analysis was the number of deaths from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure.
2.6-year follow-up results showed that the incidence of the primary outcome event in the finerenone group was 17.8% (504/2833), compared with 21.1% (600/2841) in the placebo group, (HR: 0.82; 95%CI, 0.73 ~ 0.93; P = 0.001). The key secondary outcome event rates were 13.0% (finerenone group) and 14.8% (placebo group) (HR: 0.86; 95% CI, 0.75 to 0.99; P = 0.03).
Bayer has also submitted finerenone marketing authorization in EU, China and many countries around the world, and these applications are currently under review.
Chronic kidney disease (CKD) is a common and potentially fatal condition that is often underrecognized. Compared with the general population without either disease, CKD can shorten the life expectancy of people with type 2 diabetes by as much as 16 years. As many as 40% of people with type 2 diabetes will develop chronic kidney disease. In T2D, mineralocorticoid receptor (MR) hyperactivation driven by metabolic, hemodynamic, or inflammatory and fibrotic factors is thought to contribute to CKD progression.
Article source: Bayer's KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
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