FDA approves new indication for Jardiance
Boehringer Ingelheim and Eli Lilly have received the Food and Drug Administration's green light for Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression.
"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, executive director for Research at Providence Inland Northwest Health, Regional Principal investigator for the Institute of Translational Health Sciences and professor of Medicine at the University of Washington, 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."
"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, vice president, Clinical Development and Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine at Boehringer Ingelheim. "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."
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"Following previous indications for Jardiance in heart failure and type 2 diabetes, this FDA approval now provides physicians, including nephrologists, with an important treatment option for adults living with CKD at risk for progression," said Leonard Glass, senior vice president, Diabetes Global Medical Affairs, at Lilly. "Alongside the recent CKD approval for Jardiance in the EU, this decision further bolsters our efforts to support this community globally."
Jardiance also is used to: Reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body; reduce the risk of further worsening of kidney disease, end-stage kidney disease, death due to cardiovascular disease, and hospitalization in adults with chronic kidney disease; reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease; lower blood sugar along with diet and exercise in adults and children who are 10 years of age and older with type 2 diabetes.
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