Bayer Wins Approval for CKD Drug

Bayer_Volker Hartmann/Getty Images

Volker Hartmann/Getty Images

The U.S. Food and Drug Administration (FDA) greenlit Bayer’s Kerendia (finerenone) to reduce the progression of chronic kidney disease associated with type 2 diabetes. The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes. 

Kerendia was explicitly approved to reduce the risk of kidney failure, heart attack, heart failure hospitalization, and cardiovascular death in adult patients with chronic kidney disease associated with type 2 diabetes. Although there are guideline directed therapies for CKD, many patients with chronic kidney disease associated with type 2 diabetes are at risk for disease progression and cardiovascular events. 

Amit Sharma, Vice President of Cardiovascular and Renal at Bayer, expressed excitement at bringing this new treatment for patients with CKD associated with type 2 diabetes. 

Kerendia acts by blocking the overactivation of the mineralocorticoid receptor, which contributes to fibrosis and inflammation. Those can then contribute to permanent structural kidney damage. 

“Chronic kidney disease associated with type 2 diabetes can have such a debilitating impact on patients’ lives. Unfortunately, this disease is far reaching, as up to 40 percent of all patients with type 2 diabetes develop chronic kidney disease,” Kevin Longino, chief executive officer of the National Kidney Foundation and a kidney transplant patient, said in a statement. “It is important for physicians and patients to have new treatment options that can slow chronic kidney disease progression.”

The FDA approved Kerendia based on data from the Phase III FIDELIO-DKD study. The trial demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with type 2 diabetes. 

Trial findings were published in the New England Journal of Medicine in 2020. Type 2 diabetes is the leading cause of end-stage kidney disease, when patients may need dialysis or a kidney transplant to stay alive. It is estimated that about 40% of all type 2 diabetes patients will develop chronic kidney disease. 

George Bakris, the lead study investigator for the FIDELIO-DKD study, said the patient populations included in the Phase IIII study were at risk of disease progression despite being on the current standard of care treatment to control blood pressure and blood glucose. The approval of Kerendia provides physicians with a treatment option that can give kidney protection, he said. 

Bayer expects Kerendia to be available for patients by the end of the month. The company is seeking approval in Europe. Kerendia was approved under both Fast Track and Priority Review designations. 

 

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