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Kerendia approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes


The European Commission has granted marketing authorization in the European Union ( EU ) for Finerenone under the brand name Kerendia.
Kerendia ( 10 mg or 20 mg ), a non-steroidal, selective mineralocorticoid receptor ( MR ) antagonist, is indicated for the treatment of chronic kidney disease ( stage 3 and 4 with albuminuria ) associated with type 2 diabetes ( T2D ) in adults.

Finerenone is different to existing chronic kidney disease with type 2 diabetes treatments. It acts by blocking mineralocorticoid receptor overactivation, which is thought to contribute to chronic kidney disease progression and cardiovascular damage.

The approval of Kerendia in the EU is based on the results of the pivotal phase III FIDELIO-DKD study, presented at the American Society of Nephrology’s ( ASN ) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine ( NEJM ) in October 2020.

In July 2021, Kerendia was approved by the U.S. Food and Drug Administration ( FDA ) based on the positive results of the FIDELIO-DKD phase III study.
In December 2021, Kerendia received a Grade A recommendation in the new treatment guidelines of the American Diabetes Association ( ADA ) for the treatment of patients with chronic kidney disease and type 2 diabetes who are at increased risk for cardiovascular events or chronic kidney disease progression or are unable to use a sodium-glucose cotransporter 2 inhibitor.

Kerendia is a non-steroidal, selective mineralocorticoid receptor antagonist that in preclinical studies has been shown to block harmful effects of mineralocorticoid receptor overactivation.
In type 2 diabetes, mineralocorticoid receptor overactivation is thought to contribute to chronic kidney disease progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors.

The phase III study Programme with Finerenone, FINEOVATE, currently comprises five phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA. Having randomized more than 13,000 patients with chronic kidney disease and type 2 diabetes around the world, the phase III program with Finerenone in chronic kidney disease and type 2 diabetes has included two completed and published studies, evaluating the effect of Finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.

FIDELIO-DKD ( FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease ) has investigated the efficacy and safety of Finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with chronic kidney disease and type 2 diabetes.

FIGARO-DKD ( FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease ) has investigated the efficacy and safety of Finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with chronic kidney disease and type 2 diabetes.

FIDELITY ( FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis ), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest phase III cardiorenal outcomes clinical trial program to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal cardiovascular events in more than 13,000 patients with chronic kidney disease and type 2 diabetes.
The prespecified FIDELITY pooled analysis investigated the efficacy and safety of Finerenone across the spectrum of patients with chronic kidney disease in type 2 diabetes and provided insights into the relationship between chronic kidney disease stage ( based on baseline Kidney Disease: Improving Global Outcomes risk categories ) and the effects of Finerenone on composite cardiovascular and kidney-specific endpoints.

Chronic kidney disease is a common and potentially deadly condition that is widely underrecognized.
Chronic kidney disease progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced.
Chronic kidney disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Despite guideline-directed therapies, patients with chronic kidney disease and type 2 diabetes remain at high risk of chronic kidney disease progression and cardiovascular events. It is estimated that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant. Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone. ( Xagena )

Source: Bayer, 2022

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