Reduced risk of CV morbidity and mortality demonstrated in FIGARO-DKD study

At this year’s European Society of Cardiology (ESC) Congress, positive results were presented from Bayer’s FIGARO-DKD Phase III trial of Kerendia (finerenone), providing insight into the drug’s ability to reduce risk of morbidity and mortality in diabetic kidney disease patients. The positive data from the FIGARO-DKD study will help support the use of finerenone to improve cardiorenal outcomes for kidney disease and type 2 diabetes (T2D) patients, according to GlobalData, a leading data and analytics company.

The FIGARO-DKD study, showed that cardiovascular benefit was mainly driven by a 29% decrease in hospitalization for heart failure. Bayer previously completed a Phase III study, FIDELIO-DKD. The study showed that finerenone was able to delay the progression of chronic kidney disease through reducing the combined risk of time to first incidence of kidney failure, and a sustained decrease of estimated glomerular filtration rate above 40% from baseline over a four-week period.

Kajal Jaddoo, Pharma Analyst at GlobalData, comments: “The large number of patients in each of the studies, FIGARO-DKD and FIDELIO-DKD, will likely drive a better understanding of the effects of finerenone on chronic kidney disease 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 adverse event.”

According to the Epidemiology Database within GlobalData’s PIC, the number of total prevalent cases of stage I–IV chronic kidney disease in the US, France, Germany, Italy, Spain, UK, and Japan is estimated to grow from approximately 106 million cases in 2020 to approximately 115 million cases by 2026. Bayer is looking to enter the increasingly competitive diabetic nephropathy market.

Jaddoo continues: “According to GlobalData’s Pharma Intelligence Center drug database, Bayer has two products in development for diabetic nephropathy: finerenone and fulacimstat. Fulacimstat is a first-in-class chymase inhibitor that is currently in Phase II development for the global market. As it is a first-in-class drug for diabetic nephropathy, patients will have a novel treatment option.”

More Media