Positive CHMP opinion for finerenone as new treatment for chronic kidney disease and type 2 diabetes

It is estimated that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide.

Bayer have announced the positive Committee for Medicinal Products for Human Use (CHMP) opinion of finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes.

The positive CHMP opinion is based on the results of the pivotal phase 3 FIDELIO-DKD study, investigating the effectiveness and safety of finerenone on kidney and cardiovascular outcomes in patients with CKD associated with type two diabetes. Finerenone (10mg or 20mg) is recommended for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

“Despite currently available treatment options, many patients with chronic kidney disease associated with type 2 diabetes progress to kidney failure or premature death. These patients have a critical need for treatment options that can delay kidney disease progression and reduce the risk of cardiovascular events,” shared Professor Peter Rossing, head of complications research at the Steno Diabetes Center Copenhagen. 
“Once approved, finerenone will be the first non-steroidal MR antagonist to offer adult patients living with chronic kidney disease associated with type 2 diabetes a new form of therapy to help improve kidney outcomes.”

In July 2021, finerenone was approved under the brand name Kerendia by the US Food and Drug Administration (FDA), based on the positive results of the FIDELIO-DKD phase 3 study for adult patients with CKD and type 2 diabetes. CKD is a common, generally under-recognised and potentially deadly condition. It is one of the most frequent complications arising from diabetes, with up to 40% of all patients with type 2 diabetes developing chronic kidney disease. It is also an independent risk factor of cardiovascular disease.

Patients with chronic kidney disease and type 2 diabetes are around three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.