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Kerendia/Firialta (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation. It has been granted marketing authorization for expanded indication in China for chronic kidney disease and T2D.
Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist and was approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure.
Jardiance (empagliflozin) is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2), which leads in lowering renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
JARDIANCE (empagliflozin) is a prescription medicine used to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body.
The submission is based on positive data from the FIGARO-DKD study, which demonstrated that Kerendia (finerenone) significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.
Jardiance (empagliflozin), is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.
Finerenone significantly reduced the composite primary endpoint of cardiovascular death and non-fatal cardiovascular events versus placebo when added to standard of care.
The NDA was based on Phase III FIDELIO-DKD trial data. Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist that showed renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study.
The FIDELIO-DKD data were presented in October at the American Society of Nephrology’s (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine. Based on these data, Bayer submitted finerenone for marketing authorization in the US and the EU.
The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, is the first large contemporary positive outcomes study in patients with CKD and T2D