Kerendia approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes – Bayer HealthCare

The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia from Bayer HealthCare. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

“Even when blood glucose levels and blood pressure are well-controlled, the risk of chronic kidney disease progression and cardiovascular events remains high in these patients,” said Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. “As most patients have no symptoms in the early stages, people with type 2 diabetes should regularly be monitored by their doctor for the earliest signs of kidney disease. Finerenone is the first non-steroidal, selective MR antagonist specifically developed as a new treatment option to protect patients from further kidney damage, by addressing a key cause of disease progression which is unaddressed by currently available therapies.”

p> Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage.

“The worrying reality is that chronic kidney disease in type 2 diabetes is the leading cause of end-stage kidney disease, which ultimately means that the kidneys no longer support the body’s needs and patients need dialysis or a kidney transplant to stay alive. Early intervention is associated with a better prognosis, and it is key to prevent further end-organ damage by reducing the risk of kidney function loss,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division. “The approval of Kerendia offers physicians a new path to protect these vulnerable patients by reducing their risk of cardiovascular events and delaying kidney disease progression.”

The approval of Kerendia in the EU is based on the results of the pivotal Phase III FIDELIO-DKD study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020.

In July 2021, Kerendia was approved by the FDA based on the positive results of the FIDELIO-DKD Phase III study. In December 2021, Kerendia received a Grade A recommendation in the new treatment guidelines of the American Diabetes Association (ADA), “Standards of Medical Care in Diabetes 2022” for the treatment of patients with CKD and T2D who are at increased risk for cardiovascular events or CKD progression or are unable to use a sodium-glucose cotransporter 2 inhibitor.