At this year’s American College of Cardiology (ACC) Scientific Session, positive results were presented from Bayer’s FIDELITY analyses of Kerendia (finerenone), providing insight into the drug’s ability to reduce risk of cardiovascular and kidney outcomes in diabetic kidney disease patients. The positive data from the FIDELITY trial will help support the use of finerenone to improve cardiorenal outcomes for chronic kidney disease (CKD) and type 2 diabetes (T2D) patients, according to GlobalData, a leading data and analytics company.

The FIDELITY study showed that the cardiovascular benefit was mainly driven by a 14% decrease in the risk of cardiovascular morbidity and a 23% decrease in CKD progression. Additionally, the study found that finerenone sustained a 57% decrease in the estimated glomerular filtration rate from the baseline over a four-week period.

Kajal Jaddoo, Pharma Analyst at GlobalData, comments: “The large number of patients in the FIDELITY analyses will likely drive a better understanding of the effects of finerenone on CKD and T2D. However, key opinion leaders interviewed by GlobalData have emphasized that physicians are reluctant to prescribe mineralocorticoid receptor antagonists as hyperkalemia is a common side effect.”

Bayer previously completed a Phase III study, FIDELIO-DKD. The study showed that finerenone was able to delay the progression of CKD through reducing the combined risk of time to first incidence of kidney failure, and a sustained decrease of the estimated glomerular filtration rate above 40% from the baseline over a four-week period. Furthermore, the Phase III FIGARO-DKD study showed that end-stage kidney disease occurred in 32 patients in the finerenone group compared to 49 patients in the placebo group.

Jaddoo continues: “Bayer is looking to enter the increasingly competitive diabetic nephropathy market. According to GlobalData’s Pharma Intelligence Center drug database, Bayer has two products in development for diabetic nephropathy: finerenone and fulacimstat.”