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Finerenone Approved by FDA – New Drug Fights Chronic Kidney Disease Associated with Type 2 Diabetes

The FDA approved Kerendia (finerenone) – a brand new drug which has been shown to slow the progression of chronic kidney disease for people with type 2 diabetes. The EU has also approved this drug for the same population.

Editor's Note: This article was updated to reflect Kerendia's approval in the EU.

On July 9, 2021 the FDA approved the drug Kerendia (finerenone) which has been shown to slow the progression of chronic kidney disease (CKD) that is associated with type 2 diabetes. This new medication is indicated to reduce the risk of eGFR decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure – which are all associated with CKD as a result of having type 2 diabetes.

Kerendia is a type of drug called a non-steroidal mineralocorticoid receptor antagonist (or MRA). This is the first drug in this class to be approved by the FDA for treating these specific conditions. The way the drug works is by blocking the overactivation of a receptor in your body’s kidney cells called the mineralocorticoid receptor. This reduces fibrosis (built-up scar tissue) and inflammation (the body’s normal reaction to tissue damage or infection) – both of which can cause damage to your kidneys and lead to CKD or kidney failure.

Diabetes is the leading cause of CKD and that it affects one in three adults with diabetes. Thankfully, an increasing number of drugs are being approved that help slow down the progression of CKD in people with diabetes. A number of SGLT-2 inhibitors have been shown to have clear benefits for heart and kidney health including Jardiance, Steglatro, Farxiga, and Invokana. And current and ongoing research on GLP-1 receptor agonists (such as Trulicity, Victoza, Ozempic, and Bydureon) suggests that they too may afford some protection against the progression of heart disease and CKD. With the approval of Kerendia, healthcare providers and patients now have many options to choose from to help treat and prevent this serious condition.

The approval of Kerendia follows encouraging results from the FIDELIO-DKD trial. In this trial of almost 6,000 people with type 2 diabetes who were at risk for CKD progression, Kerendia significantly reduced the risk of severe kidney outcomes by 18% over two and a half years and it reduced the risk of severe heart outcomes by 14% compared to the placebo pill.

Kerendia is now available in the US and in February, 2022, Kerendia also received approval in the European Union (EU) to be marketed for the treatment of chronic kidney disease in adults with type 2 diabetes.

Like the FDA approval in July 2021, this EU approval is based on data from the FIDELIO-DKD trial, which was published in the New England Journal of Medicine in 2020. Since its FDA approval, Kerendia was also added to the American Diabetes Association treatment guidelines, with a Grade A recommendation for slowing the progression of CKD in adults with type 2 diabetes.