The approval of Kerendia is based on results of Phase 3 FIDELIO-DKD trial and follows priority review designation granted by the US FDA
Bayer has received the US Food and Drug Administration (FDA) approval for Kerendia (finerenone) to treat a type of chronic kidney disease (CKD) related to Type 2 Diabetes (T2D).
Kerendia is indicated for reducing the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalisation in adults with CKD associated with T2D.
The drug is an advanced nonsteroidal mineralocorticoid receptor antagonist (MRA) that works by blocking overactivation of the mineralocorticoid receptor (MR).
MR overactivation is believed to contribute to fibrosis and inflammation, which may potentially lead to permanent structural kidney damage.
Bayer US cardiovascular and renal medical affairs vice president Amit Sharma said: “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.
“We are excited to bring this new kidney-focused treatment to people living with this condition.”
The US approval of Kerendia is based on the results of Phase 3 FIDELIO-DKD trial and follows priority review designation granted by the US FDA.
In Phase 3 FIDELIO-DKD trial, the treatment using Kerendia showed positive kidney and cardiovascular outcomes in patients with CKD associated with T2D.
Also, the primary outcomes were generally consistent across pre-specified subgroups, and the drug showed sustained therapeutic across the trial duration.
Bayer is planning to commercialise Kerendia in the US, from the end of this month, with a label containing warning and precaution that it may cause hyperkalemia.
Furthermore, the German life sciences company has filed a regulatory application with the European Union for the marketing authorisation of Kerendia.
FIDELIO-DKD study lead investigator George Bakris said: “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.”