Bayer’s Kerendia approved in the US to slow CKD in type 2 diabetes patients

Bayer’s first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) Kerendia has received approval in the US to slow chronic kidney disease (CKD) progression in patients with type 2 diabetes (T2D).

The US Food and Drug Administration (FDA) has cleared Kerendia (finerenone) to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalisation for heart failure in adult patients with CKD associated with T2D.

The approval is based on data from the Phase III FIDELIO-DKD renal outcomes study, which showed Kerendia significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care.

The drug also lowered the risk of a composite of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalisation, thereby by also meeting secondary targets.

“Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes,” said Amit Sharma, vice president of cardiovascular and renal, Bayer US Medical Affairs.

Kerendia is designed to block overactivation of the mineralocorticoid receptor (MR), which is believed to contribute to fibrosis and inflammation. Fibrosis and inflammation can, in turn, contribute to permanent structural kidney damage.