A New Drug Class Option for Patients with Chronic Kidney Disease Associated with Type 2 Diabetes

Photo by Christina Victoria Craft on Unsplash

July 14th, 2021 — Bayer announced this week that their first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA), finerenone (Kerendia), has received FDA approval for use in patients with chronic kidney disease (CKD) associated with type 2 diabetes¹. The approval comes following the positive results of the FIDELIO-DKD clinical trial, a Phase III double-blind study in which 5734 patients with CKD and T2D were randomized 1:1 to either finerenone or placebo. The primary outcome was a composite endpoint of kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. The key secondary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.²

Results suggested patients on finerenone experienced an 18% reduction in risk for progression of their chronic kidney disease, and a 16% reduction in risk for the composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.²

With studies estimating that up to 43.5% of patients with type 2 diabetes also present with chronic kidney disease, the population benefits of finerenone are potentially vast³, and its approval has been lauded unanimously by kidney health organizations. Kevin Longino, the CEO of the National Kidney Foundation, stated, “Chronic kidney disease associated with type 2 diabetes can have such a debilitating impact on patients’ lives. …It is important for physicians and patients to have new treatment options that can slow chronic kidney disease progression.”¹ The American Kidney Fund called it, “Another hopeful step in the treatment of diabetic kidney disease.”⁴ Bayer reports finerenone (Kerendia) will likely become available for consumer use in the U.S. by the end of July 2021¹.

For full FIDELIO-DKD study results, find the New England Journal of Medicine publication here.

References:

1. 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

2. Bakris GL, Agarwal R, Anker SD, et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020;383(23):2219–2229. doi:10.1056/NEJMoa2025845

3. Bailey, R.A., Wang, Y., Zhu, V. et al. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes 7, 415 (2014). https://doi.org/10.1186/1756-0500-7-415

4. American Kidney Fund. [@KidneyFund]. (2021, July 12). BREAKING: Today marks another hopeful step in the treatment of diabetic #kidneydisease. Innovative treatments like Kerendia can become tools to help patients slow the progression of kidney disease and prevent dangerous complications [Tweet]. Twitter. https://twitter.com/KidneyFund/status/1414660988478107650