Bayer announced the United States (US) Food and Drug Administration (FDA) has approved KERENDIA (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalisation for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
The approval is based on the results of the pivotal Phase III FIDELIO-DKD trial data that demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with T2D, published in the New England Journal of Medicine in October 2020, and follows priority review designation granted by the FDA.
“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. In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection,” said George Bakris, University of Chicago and lead FIDELIO-DKD study investigator.
The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.
KERENDIA works by blocking overactivation of the mineralocorticoid receptor (MR). Mineralocorticoid receptor overactivation is thought to contribute to fibrosis and inflammation. Fibrosis and inflammation can contribute to permanent structural kidney damage.
“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 US Medical Affairs. “We are excited to bring this new kidney-focused treatment to people living with this condition.”
KERENDIA is expected to be available in the US beginning the end of July 2021. Finerenone has also been submitted for marketing authorisation in the European Union.