FDA Grants Fast Track Designation to Empagliflozin (Jardiance) to Reduce Risk of Kidney Disease Progression and Cardiovascular Death in Adults with Chronic Kidney Disease

On the 13th, Boehringer Ingelheim and Eli Lilly and Company jointly announced that the U.S. FDA granted Fast Track designation to their SGLT2 inhibitor empagliflozin (brand name Jardiance) to reduce the risk of kidney disease progression and cardiovascular death in adult patients with chronic kidney disease.

Chronic kidney disease is the ninth leading cause of death in the United States. Approximately two-thirds of cases are attributed to metabolic disorders, such as diabetes (referred to as diabetic nephropathy), hypertension, and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality from cardiovascular disease. The majority of deaths in patients with chronic kidney disease result from cardiovascular complications, which often occur before progression to end-stage renal disease.

By inhibiting the transporter SGLT2 in the glomeruli, empagliflozin reduces the reabsorption of glucose in the kidneys, causing it to be excreted in the urine, thereby lowering blood glucose levels. The mechanism of action of empagliflozin is independent of insulin. It received FDA approval in late 2016 for reducing blood glucose levels and the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.

Previously, results from the EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced the risk of onset and progression of kidney disease and cardiovascular events by 39% in adult patients with type 2 diabetes, compared with placebo. Currently, building on the positive findings from the EMPA-REG OUTCOME trial, researchers are conducting the EMPA-KIDNEY trial. This double-blind, placebo-controlled clinical study aims to evaluate the impact of empagliflozin on the risk of kidney disease progression and cardiovascular death in 6,000 patients with chronic kidney disease, regardless of whether they have concomitant diabetes.

“Chronic kidney disease (CKD) can have a devastating impact on people’s lives. It not only impairs kidney function, potentially leading to dialysis or kidney transplantation, but also increases the risk of cardiovascular mortality,” said Dr. Mohamed Eid, Vice President of Clinical Development and Medical Affairs at Boehringer Ingelheim. “CKD is a common and life-threatening condition, yet current treatment options are limited. This has driven us to explore the therapeutic potential of empagliflozin.”

References:

[1] US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease, Retrieved March 12, 2020, from https://investor.lilly.com/news-releases/news-release-details/us-fda-grants-fast-track-designation-jardiancer-treatment

Original Title: Express | Empagliflozin Granted FDA Fast Track Designation, Reducing Mortality Risk in Patients with Chronic Kidney Disease

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