Kerendia's US label updated

2 September 2022

The US Food and Drug Administration (FDA) has approved an update to the label of Bayer’s (BAYN: DE) Kerendia (finerenone), a nonsteroidal mineralocorticoid receptor antagonist.

Kerendia was approved by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), based on the results of the FIDELIO-DKD pivotal trial.

"This label update reaffirms Kerendia as a fundamental pillar in the treatment algorithm to improve CV and renal outcomes in patients with CKD associated with T2D"With the addition of new study findings, the US label now includes data from Kerendia’s Phase III trial program investigating kidney and CV outcomes in more than 13,000 patients with CKD associated with T2D.

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