Bayer Phase III trial results prove positive for diabetes patients

pharmafile | October 4, 2021 | News story | Sales and Marketing  

Bayer has revealed positive results from their FIGARO-DKD Phase III trial of Kerendia (finerenone), which showcased the drug’s ability to reduce risk of morbidity and mortality in diabetic kidney disease patients. The results were presented at this year’s European Society of Cardiology (ESC) Congress.

According to GlobalData, a leading data and analytics company, the positive data from the trial will help support the use of finerenone to improve cardiorenal outcomes for kidney disease and Type 2 diabetes (T2D) patients.

The FIGARO-DKD study showed that cardiovascular benefit was caused by a 29% decrease in hospitalisation for heart failure. A previous Phase III study conducted by Bayer, FIDELIO-DKD, 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.

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.

“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.”

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 about 106 million cases in 2020 to roughly 115 million cases by 2026, according to the Epidemiology Database within GlobalData’s PIC.

Lina Adams

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