U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

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• The FDA accepted the company's sNDA for KERENDIA, which is being investigated for treatment of adults with CKD without diabetes receiving background standard of care.

  60% confidence

• KERENDIA met the primary endpoint in FIND-CKD, significantly reducing eGFR slope decline versus placebo.

  60% confidence

• The safety profile of KERENDIA was consistent with prior Phase III studies; serious adverse events were similar between KERENDIA and placebo (20.9% and 21.2%).

  60% confidence

• An estimated 50% to 70% of people with CKD do not have diabetes, and 63% of those who progress to end-stage kidney disease in the U.S. do not have diabetes.

  60% confidence

• KERENDIA is FDA-approved to reduce the risk of sustained eGFR decline, ESKD, CV death, non-fatal MI and HF hospitalization in adults with CKD associated with T2D; to reduce UACR in CKD associated with T1D; and to reduce CV death, HF hospitalization and urgent HF visits in HF with LVEF ≥40%.

  60% confidence

• KERENDIA showed a statistically significant reduction versus placebo in risk of a secondary composite endpoint of kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure or cardiovascular death.

  60% confidence