The Food and Drug Administration (FDA) has granted Fast Track designation for empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) to reduce the risk of kidney disease progression and cardiovascular (CV) death in adults with chronic kidney disease.
The designation is supported by data from the ongoing double-blind, placebo-controlled phase 3 EMPA-KIDNEY trial, which is comparing the effects of empagliflozin on kidney disease progression or CV death with placebo, in addition to standard of care, in patients with pre-existing chronic kidney disease. The primary composite end point is the time to first occurrence of kidney disease progression (defined as end-stage kidney disease, a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization) or CV death.
EMPA-KIDNEY was initiated based on exploratory results from the EMPA-REG OUTCOME trial, which showed a 39% reduction in the risk of new onset and worsening kidney disease for adults with type 2 diabetes mellitus (T2DM) and established CV disease treated with empagliflozin vs placebo.
“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, VP, 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.”
Jardiance, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently indicated to improve glycemic control as an adjunct to diet and exercise in adults with T2DM; and to reduce the risk of CV death in adults with T2DM and established CV disease.