Therapy Areas: Diabetes
Bayer's Kerendia Receives Updated Label to Include Findings from Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients with Chronic Kidney Disease and Type 2 Diabetes
2 September 2022 - - German healthcare company Bayer has received approval from the United States Food and Drug Administration for an update to the label for Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist, to include findings from the FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes, the company said.

FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage CKD (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2) with albuminuria to show CV benefit in patients with CKD associated with T2D.

Kerendia provides dual cardiorenal risk reduction in adults with CKD associated with T2D.

Kerendia was approved in the US by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV 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.

FIGARO-DKD showed that Kerendia significantly reduced the risk of the primary composite endpoint of time to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for heart failure by 13% (relative risk reduction, HR 0.87 [95% CI, 0.76-0.98; P=0.026]) over a median duration of follow-up of 3.4 years when added to maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in adults with CKD associated with T2D.

In FIGARO-DKD, the treatment effect was primarily driven by a 29% risk reduction in hospitalization for HF (HR 0.71 [95% CI, 0.56-0.90]).

A 10% risk reduction in CV death (HR 0.90 [95% CI, 0.74-1.09]) also contributed to the treatment effect.

With the addition of these study findings, the US label now includes data from Kerendia's comprehensive Phase III clinical trial program investigating kidney and CV outcomes in more than 13,000 patients with CKD associated with T2D.

Kerendia works by blocking overactivation of the mineralocorticoid receptor in the kidney, heart and blood vessels, which is thought to lead to inflammation and fibrosis.

Mineralocorticoid receptor overactivation is an important factor to consider when evaluating the risk of CV events and CKD progression in patients with CKD associated with T2D.
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