Empagliflozin Gets FDA Nod for CKD Without T2D or HF

Mitchel L. Zoler, PhD

September 27, 2023

The SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) has received approval from the US Food and Drug Administration (FDA) for the new indication of treating adults with chronic kidney disease (CKD) at risk of progression and without necessarily having type 2 diabetes or heart failure, which were until now the only approved clinical settings for use of empagliflozin.

This new approval for empagliflozin for treating adults with isolated CKD makes it the second agent from the class of sodium-glucose reuptake 2 (SGLT2) inhibitors to receive this indication, joining dapagliflozin (Farxiga, AstraZeneca), which received an identical isolated CKD indication more than 2 years ago, in April 2021.

Indication Based on EMPA-KIDNEY Results

Approval of the isolated CKD indication for empagliflozin rested primarily on the agent's performance in the EMPA-KIDNEY trial, results from which were first reported in November 2022 in a presentation during Kidney Week 2022 and were published simultaneously in The New England Journal of Medicine.

EMPA-KIDNEY randomly assigned 6609 adults with CKD and an estimated glomerular filtration rate (eGFR) of at least 20 mL/min/1.73m2 but less than 45 mL/min/1.73m2, or an eGFR of at least 45 mL/min/1.73m2 but less than 90 mL/min/1.73m2 plus a urinary albumin-to-creatinine ratio of at least 200 (with albumin measured in milligrams and creatinine measured in grams).

Results from this pivotal trial after median follow-up of 2.0 years showed that empagliflozin treatment reduced the primary endpoint, a composite of progression of kidney disease or death from cardiovascular causes, by a significant 28% relative to treatment with placebo.

The evidence supporting the efficacy and safety of both dapagliflozin and empagliflozin in adults with isolated CKD led the influential international nephrology organization KDIGO (Kidney Disease: Improving Global Outcomes) to include this practice recommendation in its draft 2023 updated guideline for managing people with CKD: "We suggest treating adults with eGFR ≥20 to 45 ml/min per 1.73 m2 with urine albumin-to-creatinine ratio <200 mg/g with an SGLT2 inhibitor (2B)." (Finalization of this draft, released for public comment in July 2023, had not occurred as of late September 2023.)

Empagliflozin had already received three other FDA-approved indications: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (regardless of their left ventricular ejection fraction); to reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease; and to lower blood sugar along with diet and exercise in adults and children who are at least 10 years old and have type 2 diabetes.

EMPA-KIDNEY was sponsored by Boehringer Ingelheim and Lilly, the companies that jointly market empagliflozin (Jardiance).

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