Bayer says FDA grants priority review designation for finerenone
Reuters
Last updated: May 21, 2026
Bayer has received priority review for its supplemental New Drug Application for finerenone from the U.S. Food and Drug Administration. This drug, marketed as Kerendia, is used to treat chronic kidney disease associated with type 1 diabetes.
- The U.S. Food and Drug Administration (FDA) has accepted Bayer's supplemental New Drug Application for finerenone.
- The application has been granted priority review designation by the FDA.
- Finerenone is marketed under the brand name Kerendia.
- The drug is indicated for the treatment of chronic kidney disease that is associated with type 1 diabetes.
- Bayer's application is supported by study data demonstrating finerenone's efficacy.
- The study showed that finerenone reduced the urine albumin-to-creatinine ratio by approximately 25% from baseline over a six-month period.
- This reduction was observed in adult patients with the condition when compared to a placebo.