Bayer recently announced that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted Priority Review (PR) designation for Kerendia (finerenone), which is being investigated for the treatment of adults with Type 1 Diabetes (T1D) and Chronic Kidney Disease (CKD).

If approved, Kerendia, a non-steroidal Mineralocorticoid Receptor Antagonist (MRA), would be the first MRA indicated for adults with T1D and CKD.

Carolina Aldworth, MD, MSc, Executive Medical Director, Bayer, said, “The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for Kerendia, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases. With five phase 3 trials now having achieved their primary endpoint—including FINE?ONE, which forms the basis of this submission—we’re proud that this milestone brings us one step closer to potentially addressing unmet needs among people living with Type 1 Diabetes and Chronic Kidney Disease.”

FINE-ONE is the first phase 3 study since the 1990s to show positive results for patients with T1D and CKD.

Since 2021, Kerendia has been approved to reduce the risk of cardiovascular death, hospitalisation for Heart Failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with T2D.

In July 2025, Kerendia also received FDA approval to reduce the risk of cardiovascular death, hospitalisation for heart failure, and urgent heart failure visits in adults with HF LVEF ≥40 percent.