Eli Lilly and Boehringer Ingelheim Report the US FDA’s Acceptance of sNDA for Jardiance (empagliflozin) to Treat Chronic Kidney Disease
- The sNDA was based on the P-III trial (EMPA-KIDNEY) results evaluating Jardiance (10mg) vs PBO in 6609 patients across 8 countries with CKD with/out diabetes & with/out albuminuria
- The results showed a 28% reduction in the risk of kidney disease progression or CV death. The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8 vs 29.2 events/100 patient-yrs.) in pre-specified 2EPs while the reductions in other 2EPs of hospitalization for HF or CV death or all-cause death were not statistically significant
- The safety data were consistent with the prior safety profile of Jardiance. The results were presented at ASN Kidney Week 2022 & published in NEJM
Ref: Eli Lilly | Image: Eli Lilly
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