11 October 2022 - - The American Association of Clinical Endocrinology issued an update to its Developing a Diabetes Mellitus Comprehensive Care Plan guideline, which included a grade A recommendation for Germany-based Bayer's Kerendia (finerenone), a first-in-class non-steroidal mineralocorticoid receptor antagonist (ns-MRA), for the management of patients with chronic kidney disease associated with type 2 diabetes, Bayer said.

Kerendia was approved by the FDA in July 2021 to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with T2D, based on the results of the FIDELIO-DKD pivotal trial.

The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia.

The updated AACE guideline included a recommendation for KERENDIA, an ns-MRA with proven kidney and cardiovascular disease benefits, for patients with CKD associated with T2D who have an eGFR ≥25 mL/min/1.73 m2, normal serum potassium concentration and albuminuria (urine albumin-to-creatinine ratio ≥30 mg/g) despite maximum tolerated dose of renin-angiotensin-system inhibitor.

The recommendation is based on data that demonstrated Kerendia's ability to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI and hospitalization for heart failure.

In a joint consensus statement released by the American Diabetes Association and Kidney Disease: Improving Global Outcomes (KDIGO) earlier this month, the clinical bodies recommended inclusion of Kerendia in the treatment regimen of patients with CKD associated with T2D who have an eGFR ≥25 mL/min/1.73 m2, normal serum potassium concentration and albuminuria (urine albumin-to-creatinine ratio ≥30 mg/g) despite maximum tolerated dose of RAS inhibitor.