New data indicate positive effects of Kerendia on mortality in patients with chronic kidney disease and type 2 diabetes

While in the overall population of FIDELITY the effect of finerenone on all-cause and CV mortality narrowly missed statistical significance, new data from a prespecified exploratory on-treatment analysis from FIDELITY indicate that both of these outcomes were reduced with finerenone versus placebo in this population. The positive effect of finerenone on all mortality outcomes was consistent across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes, regardless of baseline eGFR or UACR values, and appeared to be more pronounced in patients with a higher baseline eGFR. CV mortality was the most common cause of mortality in the study.

The mean age of the FIDELITY population was 64.8 years, and 69.8% of patients were male. At baseline, patients had a mean eGFR of 57.6 ml/min/1.73 m2 and the median UACR was 515 mg/g. CV medications were used by most patients (99.8% on a renin-angiotensin system (RAS)-blocking therapy, 72.2% on statins and 49.9% on beta-blockers). In the overall population, the incidence of all-cause mortality was 8.5% with finerenone vs 9.4% with placebo (HR 0.89 [95% CI: 0.79- >1.00]; p=0.051). CV mortality was reported as the most common cause of death (4.9% with finerenone vs 5.6% with placebo), followed by mortality caused by infection (1.5% with finerenone vs 1.4% with placebo) and malignancy (1.2% with finerenone vs 1.6% with placebo).

Finerenone was found to significantly reduce sudden cardiac death vs placebo (HR 0.75 [95% CI: 0.57- <1.00]; p="0.046)." prespecified on-treatment analyses revealed significant reductions in the incidence of all-cause mortality with finerenone vs placebo (hr 0.82 [95% ci 0.70-0.96]; p="0.014)" and the incidence of cv mortality with finerenone vs placebo (hr 0.82 [95% ci 0.67-0.99]; p="0.040)." event probability analyses for time to cv mortality at year 4 showed that the benefit of finerenone was consistent irrespective of baseline egfr and uacr, and a more pronounced effect was observed with finerenone vs placebo in patients with an egfr of ?60 ml min 1.73m2.

“Despite optimized blood glucose and blood pressure control, many patients with chronic kidney disease and type 2 diabetes continue to progress to kidney failure and are at a significantly increased risk of cardiovascular death,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “The exploratory analysis presented demonstrates the potential of finerenone to reduce the risk of mortality amongst this vulnerable patient population, and keep them healthier for longer.”

Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization by the FDA in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. Based on the positive results of both pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD, Kerendia was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare (MHLW). Further regulatory approvals by other health authorities in multiple other countries have been granted or are currently pending following submissions for marketing authorization.