Priority review granted for Kerendia in Type 1 diabetes and kidney disease

The FDA accepted Bayer’s supplemental new drug application (sNDA) and granted Priority Review designation for Kerendia (finerenone) as a treatment for adults with Type 1 diabetes (T1D) and chronic kidney disease (CKD).

Type 1 diabetes is a disease where the immune system destroys insulin-producing beta cells in pancreatic islets; about 2 million Americans have Type 1 diabetes. Approximately 20% to 30% of people in the United States with Type 1 diabetes also have chronic kidney disease, which puts them at risk of cardiovascular events and kidney failure.

If approved, Kerendia would be the first non-steroidal mineralocorticoid receptor antagonist for adults with Type 1 diabetes and chronic kidney disease. A mineralocorticoid receptor is a type of protein that acts as a sensor for steroid hormones, and overactivation of this protein is linked to cardiovascular disease, heart failure and chronic kidney disease. By targeting the mineralocorticoid receptor pathway, Kerendia stops the cascade of inflammation and fibrosis of the kidneys.

Kerendia was approved by the FDA in July 2021 to slow the progression of chronic kidney disease associated with Type 2 diabetes. Additionally, the FDA approved Kerendia in 2025 to treat adults with heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater. Kerendia is an oral therapy that has a wholesale acquisition cost of $685.81 for 30 tablets. Bayer offers a $0 copay program for commercially insured patients.

The sNDA was supported by the phase 3 FINE-ONE trial, which showed Kerendia significantly reduced urine albumin-to-creatinine ratio (UACR) over six months compared with placebo. UACR is an important marker of cardiovascular risk and kidney disease progression.

The application was also supported by pooled phase 3 data from the FIDELIO-DKD and FIGARO-DKD trials in adult patients with chronic kidney disease associated with Type 2 diabetes.

In the FINE-ONE study, safety and tolerability were consistent with previous trials. The rate of treatment-emergent adverse events (TEAEs) was 47.1% for those treated with Kerendia and 49.2% for placebo. The rate of treatment-emergent serious adverse events was 11.8% for Kerendia and 11.5% for placebo. Hyperkalemia (high potassium levels) was observed more frequently with Kerendia (10.1%) compared with placebo (3.3%).