Published on 23 Jan 2023 on Zacks via Yahoo Finance
Lilly (LLY) Jardiance Kidney Disease sNDA Gets FDA Acceptance
Eli Lilly and Company LLY and partner Boehringer Ingelheim announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its SGLT-2 inhibitor Jardiance (empagliflozin) for chronic kidney disease (CKD) indication.
The sNDA, which seeks approval for Jardiance, Lilly’s blockbuster diabetes once-daily medicine, to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD, was based on data from the EMPA-KIDNEY phase III study. Data from the study showed that treatment with Jardiance plus standard of care led to a 28% reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD compared with placebo on top of standard of care.
The FDA had granted Fast Track designation to Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD in March 2020.