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FDA Approves Bayer’s Kerendia for Chronic Kidney Disease Associated With Type 2 Diabetes

FDA Approves Bayer’s Kerendia for Chronic Kidney Disease Associated With Type 2 Diabetes

Bayer’s Kerendia (finerenone) has secured FDA approval for treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes.

Kerendia is a nonsteroidal mineralocorticoid receptor antagonist intended to slow CKD progression, reduce the risk of kidney failure, heart attack, heart failure hospitalization and cardiovascular death.

The FDA approval comes after a phase 3 trial of 5,674 patients in which Kerendia treatment resulted in a lower risk of CKD progression and cardiovascular events than placebo.

The incidence of CKD is as high as 40 percent among type 2 diabetes patients.

About  Kerendia

Finerenone, sold under the brand name Kerendia, is a medication used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA). 

Common side effects include hyperkalemia (high levels of potassium), hypotension (low blood pressure), and hyponatremia (low levels of sodium). 

Finerenone was approved for medical use in the United States in July 2021.

February 23, 2022

https://www.fdanews.com/


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