20 January 2023 - The supplemental new drug application is based on results from the landmark EMPA-KIDNEY Phase 3 trial, which showed Jardiance (empagliflozin) tablets significantly reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% (absolute risk reduction: 3.8%) compared with placebo, both on top of standard of care.
The US FDA has accepted a supplemental new drug application 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, Boehringer Ingelheim and Eli Lilly announced.