Bayer gets FDA OK for Kerendia
The Food and Drug Administration has approved Bayer's Kerendia (finerenone), a new drug indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease associated with Type 2 diabetes.
“The patient population included in the trial that supported the approval of Kerendia were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,” said George Bakris, University of Chicago and lead study investigator. “In people with chronic kidney disease associated with Type 2 diabetes, physicians now have a new treatment to provide kidney protection.”
“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 U.S. Medical Affairs. “We are excited to bring this new kidney-focused treatment to people living with this condition.”
Kerendia is expected to be available at the end of July.