Bayer submits regulatory applications for finerenone in U.S. and EU for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)

Regulatory submissions for this potential first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist are based on positive data from phase III FIDELIO-DKD study indicating lower risks of CKD progression and cardiovascular events than placebo.

SPS commentary:

The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial in 5734 patients reported that during a median follow-up of 2.6 years, a primary outcome event (kidney failure, a sustained decrease of at least 40% in eGFR from baseline, or death from renal causes) occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in placebo group (hazard ratio, 0.82; 95% CI, 0.73 to 0.93; p=0.001).

Biospace Inc.

Resource links:

FIDELIO-DKD study