Phase III FIGARO-DKD study of BAY 94 8862 meets primary endpoint in patients with chronic kidney disease and type 2 diabetes.- Bayer HealthCare

Bayer’s Phase III cardiovascular outcomes study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug BAY 94 8862 (finerenone) versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has met its primary endpoint. The study showed finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular (CV) death or non-fatal CV events (myocardial infarction, stroke, or hospitalization for heart failure). The Phase III FIGARO-DKD study included more patients with earlier stage CKD and T2D compared to the FIDELIO-DKD study, which was the first of two Phase III studies investigating finerenone in patients with CKD and T2D. Patients were randomized to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of the guideline directed therapies angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs).The new drug application (NDA) currently under review by the U.S. FDA for Priority Review was based on positive data from the Phase III FIDELIO-DKD study. Results from that trial were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published in the New England Journal of Medicine in October 2020. The clinical data from FIGARO-DKD will be presented at an upcoming scientific meeting.