FDA Approves Finerenone for Patients with CKD and Type 2 Diabetes

July 9, 2021
Jonathan Alicea

Jonathan Alicea is an assistant editor for HCPLive. He graduated from Princeton University with a degree with English and minors in Linguistics and Theater. He spends his free time writing plays, playing PlayStation, enjoying the company of his 2 pugs, and navigating a right-handed world as a lefty. You can email him at jalicea@mjhlifesciences.com.

Finerenone was shown to reduce risk for kidney decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure.

The US Food and Drug Administration (FDA) approved finerenone (Kerendia) tablets for kidney decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

This approval was granted to Bayer Healthcare under priority review and fast track designations.

Currently, diabetes—itself an epidemic—is the leading cause of chronic kidney disease and kidney failure in the United States. Such kidney-related conditions increase risk for fluid/waste complications and heart disease.

Supporting data

Approval was based on the randomized, multicenter, placebo-controlled FIDELIO-DKD study, which enrolled patients with chronic kidney disease linked to type 2 diabetes.

The study investigators randomly assigned 5674 patients to either finerenone or placebo. They then assessed the number of patients who progressed to the composite endpoint, defined as ≥40% reduction in kidney function, progression to kidney failure, or kidney death.

Results demonstrated that 504 of the 2833 patients who received treatment had ≥1 of the events in the composite endpoint—compared to 600 of the 2841 patients who received placebo.

The investigators also found that 367 patients on finerenone experienced cardiovascular death, non-fatal heart attack, non-fatal stroke, and/or hospitalization for heart failure—compared to 420 placebo patients.

Side effects associated with finerenone were hyperkalemia, hypotension, and hyponatremia.

Additional Data

Bayer recently announced that their ongoing Phase 3 FIGARO-DKD, which enrolled a higher proportion of patients with earlier stage chronic kidney disease and type 2 diabetes, similarly met endpoint.

As such, the nonsteroidal, selective mineralocorticoid receptor antagonist significantly reduced the composite risk of time to first occurrence of cardiovascular death or non-fatal cardiovascular events including myocardial infarction, stroke, or hospitalization for heart failure in patients.

These findings were announced this past May.


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