The Study of Finerenone and Type 2 diabetes Related Early Chronic Nephropathy

On March 16th, Bayer announced that it had submitted an application for type II change to the European Medicines Agency (EMA), seeking to expand the indications of finerenone raw material to include early chronic kidney disease (CKD) related to type II diabetes (T2D).

This submission is based on positive data from the FIGARO-DKD study, which shows that finerenone significantly reduces the risk of cardiovascular events in adult patients with CKD and T2D. FIGARO-DKD includes patients with various disease severity, including stage 1-4 CKD related to T2D. The test results were announced at the 2021 ESC conference and published in the New England Journal of Medicine. FIDELIO-DKD and FIGARO-DKD are part of the largest phase III clinical trial project among CKD and T2D so far, which shows positive renal and cardiovascular (CV) results in patients with chronic kidney disease related to type 2 diabetes.

Based on the positive results of Fidelio-DKD phase III study, in February 2022, finerenone was approved in the European Union for adult patients with chronic kidney disease (stage 3 and 4 albuminuria) related to type 2 diabetes. In July, 2021, the US Food and Drug Administration (FDA) approved the use of finerenone to reduce the risk of continuous decline of glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death, nonfatal myocardial infarction and heart failure in adult patients with type 2 diabetes (T2D)-related chronic kidney disease (CKD). Finerenone has also submitted listing licenses in many other countries around the world, and these applications are currently under review.

Finerenone's Phase III research plan FINEOVATE currently includes five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and FIONA, and Phase II study CONFIDENCE.

More than 13,000 patients with CKD and T2D were randomly assigned worldwide. The Phase III plan of using Finerenone in CKD and T2D included two completed and published studies to evaluate the effects of 98% Pure Finerenone and placebo on renal and cardiovascular outcomes above the standard of care.

FIDELIO-DKD(FInerenone in reducing renal failure and progression of diabetic nephropathy) studied the efficacy and safety of FInerenone in reducing renal failure and progression of nephropathy in about 5700 CKD and T2D patients compared with placebo.

FIGARO-DKD(FInerenone reduces cardiovascular mortality and morbidity in diabetic nephropathy) The efficacy and safety of finerenone in reducing cardiovascular morbidity and mortality compared with placebo were studied in about 7400 CKD and T2D patients, except for nursing standards.

In November 2021, Bayer announced the launch of FIONA, a multi-center, randomized, double-blind, placebo-controlled phase III study, aiming to study the efficacy, safety and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone in addition to nursing standards for about 200 pediatric patients with chronic kidney disease (CKD) and severe increase in proteinuria.

In September 2021, Bayer announced the launch of phase III study FIND-CKD, which is a multicenter, randomized, double-blind and placebo-controlled phase III study. In addition to guiding the treatment of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease (including hypertension and chronic glomerulonephritis (renal inflammation)), it also studied the efficacy and safety of finerenone.

In June, 2020, Bayer announced the launch of FINEARTS-HF study, which is a multicenter, randomized, double-blind, placebo-controlled phase III study. It aims to compare finerenone powder with placebo in more than 5,500 patients with symptomatic heart failure (grade II-IV of new york Heart Association) with preserved ejection fraction (that is, left ventricular ejection fraction =40%). The main purpose of this study is to prove that finerenone is superior to placebo in reducing the composite end point incidence of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalization for heart failure or emergency heart failure).

In February, 2022, Bayer announced the launch of the CONFIDENCE study, which is a phase II three-group study. It will investigate that patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) will receive the initial combined treatment of finerenone and SGLT2 inhibitor empagliflozin, and compare them with finerenone and empagliflozin alone. The main purpose of this study is to prove that the simultaneous use of finerenone and empagliflozin is superior to that of empagliflozin or finerenone alone in reducing urinary albumin/creatinine ratio (UACR).

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