Finerenone Granted FDA Approval to Reduce Risk of Kidney, Heart Complications in Adults with Chronic Kidney Disease, Type 2 Diabetes

The approval marks the first nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in individuals with chronic kidney disease associated with type 2 diabetes.

The FDA has approved finerenone (Kerendia; Bayer Healthcare) to reduce the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attack, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.1

Diabetes is closely associated with chronic kidney disease and kidney failure among adults in the United States, according to a press release. Diabetes can damage the kidneys, resulting in defective filtering of the blood and complications related to fluid, electrolytes, and waste build-up in the body. Chronic kidney disease can also progress to kidney failure and puts patients at a high risk of heart disease.1

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

Investigators analyzed the efficacy of finerenone to improve kidney and heart outcomes in a randomized, multicenter, double-blind, placebo-controlled study of adults with chronic kidney disease associated with type 2 diabetes. Researchers randomized 5674 patients to receive either finerenone tablets or a placebo.1

“The patient population included in the trial that supported the approval of Kerendia were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,” said George Bakris, MD, lead study investigator of the FIDELIO-DKD trial, in a press release. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”2

Results were compared for the patients whose disease progressed to a composite endpoint, including at least a 40% reduction in kidney function, progression to kidney failure, or kidney death. According to the press release, 504 of 2833 patients who received finerenone had at least 1 of the events in the composite endpoint, compared to 600 of 2841 patients who received a placebo.1

The investigators also compared the 2 groups for the number of patients who experienced cardiovascular death, a nonfatal heart attack, nonfatal stroke, or hospitalization for heart failure. They found that 367 of 2833 patients receiving finerenone had at least 1 of these events, compared to 420 of 2841 patients in the placebo arm. Based on this data, they said the treatment showed a reduction in the risk of cardiovascular death, nonfatal heart attack, and hospitalization for heart failure.1

Adverse effects associated with finerenone can include hyperkalemia, hypotension, and hyponatremia. Individuals with adrenal insufficiency and those receiving simultaneous treatment with strong CYP3A4 inhibitors should not receive finerenone, according to the press release.1

“Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes,” said Amit Sharma, MD, vice president of cardiovascular and renal at Bayer US Medical Affairs, in a press release. “We are excited to bring this new kidney-focused treatment to people living with this condition.”2

REFERENCE

1. FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes. FDA. July 9, 2021. Accessed July 12, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease

2. Bayer’s Kerendia (finerenone) Receives US FDA Approval for Treatment of Patients With Chronic Kidney Disease Associated With Type 2 Diabetes. News release. July 9, 2021. Accessed July 12, 2021. https://bayer2019tf.q4web.com/news/news-details/2021/Bayers-KERENDIA-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes/default.aspx