FDA Grants Fast Track Designation to Jardiance for Chronic Kidney Disease

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Jardiance® (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company announced. This Fast Track designation for Jardiance underscores the urgent need for additional treatment options for the over 30 million Americans living with chronic kidney disease, many of whom are at risk of progressing to end-stage kidney disease.

"Chronic kidney disease can have a devastating impact on people's lives. Not only does it cause damage to the kidneys that can eventually lead to the need for dialysis or transplant, but it could also increase the risk of cardiovascular death," said Mohamed Eid, M.D., M.P.H., M.H.A, vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Chronic kidney disease is a common and deadly condition, and there are still only limited treatment options, which is what motivates us to explore the potential role Jardiance may play in improving outcomes."

Chronic kidney disease is associated with an increased risk of premature death from cardiovascular causes and is the ninth leading cause of death in the U.S. About two-thirds of cases are attributed to metabolic conditions such as diabetes (known as diabetic kidney disease), hypertension and obesity.

"We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease."

The ongoing EMPA-KIDNEY clinical study is evaluating the effect of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes. The EMPA-KIDNEY study was initiated based on promising exploratory results from the landmark EMPA-REG OUTCOME® trial, which found that treatment with Jardiance reduced the risk of new-onset and worsening kidney disease by 39 percent in adults with type 2 diabetes and established cardiovascular disease compared with placebo.

EMPA-KIDNEY is being independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), in partnership with the Duke Clinical Research Institute. Boehringer Ingelheim and Lilly are providing the funding for the study.

Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

In June 2019, the FDA granted Fast Track designation to the clinical investigation of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

EMPA-KIDNEY is a multinational randomized, double-blind, placebo-controlled clinical trial. It is designed to evaluate the effect of Jardiance on kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as dialysis or kidney transplantation), a sustained decline in eGFR to <10 mL/min/1.73 m2, renal death, or a sustained decline of ≥40% in eGFR from randomization. EMPA-KIDNEY includes adults with established chronic kidney disease both with and without diabetes.

The study is a global trial aiming to randomize about 6,000 participants to receive either Jardiance 10 mg once daily or placebo, each on top of standard of care.

Chronic kidney disease is defined as a progressive decline of kidney function over time. About two-thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes (known as diabetic kidney disease), hypertension and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease. Chronic kidney disease affects approximately 15 percent of adults in the United States and treatment costs are estimated to exceed $48 billion annually. Since there are currently only few treatment options, the overarching unmet medical need for additional treatment options in chronic kidney disease is evident.

Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.

Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. We remain committed to developing treatments with broad cardiorenal metabolic effects, which may help improve outcomes for people with serious chronic conditions such as these.

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