FDA Fast Track designation is to investigate whether the diabetes medication can also reduce kidney disease progression.
Jardiance® (empagliflozin) was granted Fast Track designation on March 12, 2020 by the US Food and Drug Administration (FDA) to investigate whether it can reduce the risk of kidney disease progression and cardiovascular (CV) death in adults with chronic kidney disease (CKD).
“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, MD, PhD, vice president of Product Development at Eli Lilly, in a company press release. "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 Fast Track designation emphasizes the need for more treatment options for the >30 million Americans living with CKD, which is linked to a higher risk of premature death from CV causes, the press release noted.
The ongoing EMPA-KIDNEY clinical trial aims to determine the effect of the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin on the progression of kidney disease and the occurrence of CV death in adults with CKD with and without diabetes.
The multinational, randomized, double-blind, placebo-controlled trial was initiated based on the results from the landmark EMPA-REG-OUTCOME trial, which showed empagliflozin reduced the risk of new-onset and worsening kidney disease by 39% in adults with type 2 diabetes and CV disease vs placebo.
The primary outcome of EMPA-KIDNEY is defined as time to a first event of either CV death or kidney disease progression, defined as end-stage kidney disease, 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.
"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," said Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, in the same press release.
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