Kerendia receives updated label from the FDA to include findings from Phase III FIGARO-DKD cardiovascular outcomes study. Bayer.

The positive data from the pivotal Phase III FIGARO-DKD study demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine I previously cited).

Patients living with chronic kidney disease associated with type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone. FIGARO-DKD is the first contemporary Phase III CV outcomes trial to show CV benefit in a patient population where the majority of patients was in earlier CKD stages (stages 1-2 CKD, defined as estimated glomerular filtration rate [eGFR] ?60 ml/min/1.73m2) with albuminuria. With the addition of these study findings, the U.S. label now includes clinical trial data from more than 13,000 patients with CKD associated with T2D based on FIDELIO-DKD and FIGARO-DKD.

“Patients need to be screened regularly and treated early to prevent them from progressing to more advanced stages of chronic kidney disease, as this may lead to better outcomes for these patients, potentially preventing cardiovascular complications and death,” said Dr. Michael Devoy, Chief Medical Officer of Bayer AG's Pharmaceutical Division. “At Bayer, we are committed to providing treatment options that offer clinically meaningful benefits for patients. Reflecting the positive data from the pivotal Phase III FIGARO-DKD study on the reduction of the risk of cardiovascular events, the U.S.-label update announced today reaffirms Kerendia as a fundamental pillar in the treatment algorithm to improve outcomes in patients with chronic kidney disease associated with type 2 diabetes.”

Kerendia offers an alternative pathway to treating chronic kidney disease associated with type 2 diabetes by blocking mineralocorticoid receptor (MR) overactivation, which contributes to CKD progression and cardiovascular damage. Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization by the U.S. FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI), and hospitalization for heart failure in adult patients with CKD associated with T2D.