Boehringer Ingelheim and Eli Lilly Receive the US FDA’s Approval of Jardiance (empagliflozin) for Adults with Chronic Kidney Disease
Shots:
- The US FDA has approved Jardiance (10mg) to reduce the risk of sustained decline in eGFR, end-stage kidney disease, CV death & hospitalization in adults with CKD at risk of progression
- The approval was based on the P-III trial (EMPA-KIDNEY) evaluating Jardiance (10mg, qd) vs PBO in 6609 adults with CKD with/out type 2 diabetes across 8 countries, showed 28% relative risk reduction (absolute risk reduction 3.6% per patient-year at risk) over PBO when used with SoC for the composite 1EPs of kidney disease progression or cardiovascular death, event rate for Jardiance was 13.1% vs 16.9%
- The results were consistent across prespecified subgroups & demonstrated a 14% reduction in risk of first & recurrent hospitalization
Ref: Eli Lilly | Image: Boehringer
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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.