Eli Lilly and Boehringer Ingelheim Report the US FDA’s Acceptance of sNDA for Jardiance (empagliflozin) to Treat Chronic Kidney Disease
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
