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