FDA OKs Finerenone for Chronic Kidney Disease Associated With Type 2 Diabetes

The FDA has approved finerenone (Kerendia; Bayer) tablets to reduce complications in adults with chronic kidney disease (CKD) associated with type 2 diabetes.¹

Finerenone is the first and only nonsteroidal mineralocorticoid receptor antagonist approved for adults with CKD associated with type 2 diabetes. It is indicated to slow CKD progression, reduce the risk of kidney failure, heart attack, heart failure hospitalization, and cardiovascular death. Many individuals with CKD associated with type 2 diabetes are at risk for disease progression and cardiovascular events and thus can be significantly helped by this new treatment option.²

Diabetes is the leading cause of CKD and kidney failure in the United States. Patients with CKD and diabetes can experience complications related to fluid, electrolytes, and bodily waste buildup in the body as a result of faulty filtering. Further, this disease can sometimes progress to kidney failure and cause an elevated risk of heart disease.¹

The effectiveness of finerenone in preventing kidney and heart complications was studied in the randomized, multicenter, double-blind, placebo-controlled phase 3 FIDELIO-DKD trial. A total of 5674 adult patients with CKD associated with type 2 diabetes were included in the study. Patients were randomly assigned to receive either finerenone or a placebo. The investigators compared the 2 groups for the number of patients whose disease progressed to a combined end point: those with at least 40% reduction in kidney function, progression to kidney failure, or kidney death. The results of this study showed that 504 of the 2833 patients in the study experienced 1 of the events in the combined end point. This was compared with the 600 of the 2841 patients who received a placebo.¹

Related: Flash Glucose Monitoring Vs Self-Monitoring in Diabetic Chronic Kidney Disease

Investigators looked at the 2 groups further to examine the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. The results showed that 367 of the 2833 patients receiving finerenone had at least 1 of the events in the combined end point compared with 420 of the 2841 patients who received a placebo.

The adverse effects of this drug include high levels of potassium, low blood pressure, and low levels of sodium. Patients with low hormone levels or adrenal insufficiency and those receiving simultaneous treatment with strong cytochrome P450 3A4 inhibitors should not take this medication, according to the FDA.

Finerenone previously received priority review and fast track designations for this application. The FDA granted the approval of this medication to Bayer Healthcare.¹

References

1. Bayer's KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes. News release. Bayer United States of America; July 9, 2021. Accessed July 13, 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.
2. FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes. News release. U.S. Food and Drug Administration; July 9, 2021. Accessed July 13, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease.