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# Bayer: More Positive Kidney Disease Drug Data
- URL: https://www.fdaweb.com/bayer-more-positive-kidney-disease-drug-data/
- Published: 2021-05-10T12:00:00.000Z
- Updated: 2026-09-14T16:58:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149279

Bayer is reporting positive data from a second Phase 3 study (FIGARO-DKD) that evaluated the safety and efficacy of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and Type 2 diabetes. FIGARO-DKD met its primary endpoint, demonstrating that finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular (CV) death or non-fatal CV events (myocardial infarction, stroke, or heart failure hospitalization), [according to the company](https://media.bayer.de/baynews/baynews.nsf/id/Bayers-finerenone-meets-primary-endpoint-Phase-III-FIGARO-DKD-cardiovascular-outcomes-study-patients?ref=fdaweb.com).

In January, FDA accepted for priority review a Bayer NDA for finerenone based on data from the first Phase 3 trial (FIDELIO-DKD). Finerenone is described by the company as a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has demonstrated positive kidney and cardiovascular outcomes in patients with CKD and Type 2 diabetes.

Meanwhile, Bayer has begun the Phase 3 FINEARTS-HF study, which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction greater than 40%. The study aims to demonstrate finerenone’s superiority over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure events.