Pharma Focus Asia

US FDA Accepts Supplemental New Drug Application for Jardiance®

Wednesday, January 25, 2023

Boehringer Ingelheim and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

Initially approved in 2014, Jardiance is a daily one tablet used along with diet and exercise to reduce blood sugar levels 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 also applicable to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure.

The supplemental new drug application is based on results from the EMPA-KIDNEY phase III trial, which showed Jardiance® (empagliflozin) tablets significantly reduced the risk of progression of kidney disease* or cardiovascular death (absolute risk reduction) by 28% in adults with CKD. ). [ARR]: 3.8%) compared to placebo, both on top of standard of care.

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