FDA OKs Dapagliflozin for Chronic Kidney Disease

The FDA has approved dapagliflozin (Farxiga; AstraZeneca) for use in patients with chronic kidney disease (CKD) at risk of progression.

Dapagliflozin was already approved for uses in diabetes and heart failure; the new indication expands its use to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure (hHF).

This approval was based on results from the DAPA-CKD phase 3 trial, which demonstrated that dapagliflozin, in addition to standard-of-care treatment, was effective in reducing the risk of worsening disease. The study included patients with CKD stages 2 to 4 and elevated urinary albumin excretion.

According to the findings, dapagliflozin plus standard of care lowered the relative risk of worsening renal function, onset of ESKD, or risk of CV or renal death by 39% compared with placebo (P<.0001). Over the median time in study of 2.4 years, the absolute risk reduction (ARR) was 5.3%. Additionally, dapagliflozin significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, P=0.0035) compared with placebo.

In exploratory analyses of the DECLARE-TMI 58 phase 3 clinical trial, results showed that dapagliflozin is also likely to be effective in patients with less advanced CKD. However, dapagliflozin is not recommended in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease, as it is not expected to be effective in these populations, according to AstraZeneca.

“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status,” Hiddo L. Heerspink, PhD, PharmD, University Medical Center Groningen, co-chair of the DAPA-CKD trial and its executive committee, said in a statement. “This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease.”

Reference

1. FARXIGA approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type 2 diabetes. News release. AstraZeneca; April 30, 2021. Accessed May 3, 2021. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2021/farxiga-approved-in-the-us-for-the-treatment-of-chronic-kidney-disease-in-patients-at-risk-of-progression-with-and-without-type-2-diabetes-04302021.html