- FDA approves empagliflozin (Jardiance) for reducing kidney decline, death, and hospitalization risk in at-risk patients.
- Approval was announced on September 22, 2023.
- Approval based on data from the phase 3 EMPA-KIDNEY trial.
The US Food and Drug Administration has approved empagliflozin (Jardiance) for use in the management of chronic kidney disease in patients at risk of progression, according to an announcement by Boehringer Ingelheim and Eli Lilly and Company.1
Announced on September 22, 2023, the approval, which is based on the results of the phase 3 EMPA-KIDNEY trial, indicates the agent for reducing the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression and comes just more than 18 months after the agent received a historic indication for use in treatment of heart failure regardless of ejection fraction.1,2
“This approval provides healthcare professionals in the U.S. with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations,” said Katherine Tuttle, MD, executive director for Research at Providence Inland Northwest Health and EMPA-KIDNEY steering committee member. “The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase III trial are welcome news for adults living with CKD in this country.”
The September 22, 2023 approval of empagliflozin for chronic kidney disease is the culmination of a decade-long ascent of the agent, and the SGLT2 inhibitor class as a whole, into the cardiometabolic spotlight. As part of FDA’s guidance for antidiabetes medications, Boehringer Ingelheim and Eli Lilly launched the EMPA-REG Outcome trial in July 2010. Designed to demonstrate the cardiovascular safety of empagliflozin and the SLGT2 inhibitor class, the trial produced evidence demonstrating use could lower cardiovascular risk in people with type 2 diabetes.3
These results, which were published in the New England Journal of Medicine in 2015, spurred further exploration into potential uses for the agent. This would lead to subsequent trials and approvals in populations with and without type 2 diabetes for heart failure with reduced and preserved ejection fraction. During the same time period, AstraZeneca’s dapagliflozin underwent a similar clinical trial program and emerged with additional indications for heart failure regardless of ejection fraction and chronic kidney disease.3 With the September 22, 2023 approval, empagliflozin joined dapagliflozin as the only agents within the class to boast indications for type 2 diabetes, heart failure, and chronic kidney disease.1
Stopped prematurely on the basis of a recommendation from the trial’s Independent Data Monitoring Committee due to “clear positive efficacy”, EMPA-KIDNEY was designed as an international, randomized, parallel-group, double-blind, placebo-controlled, clinical trial and enrolled adult patients without diabetes, patients with an eGFR of less than 30 ml/min/1.73 m2, and patients with low levels of proteinuria.4
The trial enrolled a total of 6609 patients who underwent randomization in a 1:1 ratio to empagliflozin. These patients were followed for a median of 2.0 years and the primary outcome of interest was a composite of progression of kidney disease or death from cardiovascular causes.4
Upon analysis, progression of kidney disease or death from cardiovascular causes occurred in 13.1% of the empagliflozin group and 16.9% in the placebo group (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.64-0.82; P < .001). Further analysis suggested use of empagliflozin was associated with a reduction in risk of hospitalization for any cause (HR, 0.86; 95% CI, 0.78-0.95; P =.003). 4
"CKD affects more than one in seven adults in the U.S., 90% of whom are undiagnosed, and it remains a significantly under-recognized public health crisis," said Mohamed Eid, MD, MPH, MBA, vice president of Clinical Development and Medical Affairs in Cardio-Renal-Metabolism & Respiratory Medicine at Boehringer Ingelheim Pharmaceuticals, Inc.1 "Hospitalizations account for a third to a half of total healthcare costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation. Given the clinically demonstrated benefits of Jardiance, we are proud to now be able to offer this option to adults with CKD at risk for progression."