The FDA ( U.S. Food and Drug Administration ) has approved Kerendia ( Finerenone ), the first non-steroidal, selective mineralocorticoid receptor ( MR ) antagonist.
Finerenone 10 mg or 20 mg is indicated 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 ).
The approval of Kerendia by the FDA is based on the positive results of the pivotal phase III FIDELIO-DKD study.
Finerenone is a novel, non-steroidal, selective antagonist of the mineralocorticoid receptor that has been shown to block harmful effects of mineralocorticoid receptor overactivation.
In type 2 diabetes, mineralocorticoid receptor overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors.
Having randomized more than 13,000 patients with chronic kidney disease and type 2 diabetes around the world, the phase III programme with Finerenone in chronic kidney disease and type 2 diabetes comprises two studies, evaluating the effect of Finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.
FIDELIO-DKD ( FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease ) has investigated the efficacy and safety of Finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with chronic kidney disease and type 2 diabetes.
FIGARO-DKD ( FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease ) has investigated the efficacy and safety of Finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with chronic kidney disease and type 2 diabetes across 47 countries including sites in Europe, Japan, China and the U.S.
The study has met its primary endpoint.
Chronic kidney disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.
Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.
Despite guideline-directed therapies, patients with chronic kidney disease and type 2 diabetes remain at high risk of CKD progression and cardiovascular events.
It is estimated that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide.
Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. ( Xagena )
Source: Bayer, 2021