Monday, July 15, 2024

FDA Approves Jardiance® (empagliflozin) to Reduce Risks in Chronic Kidney Disease

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The FDA has approved Jardiance® (empagliflozin) 10 mg tablets, a significant development announced by Boehringer Ingelheim and Eli Lilly and Company. This approval is a critical addition to the armamentarium of healthcare professionals in the U.S. for adults grappling with chronic kidney disease (CKD) at risk of progression. Jardiance aims to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization.

CKD affects a substantial portion of the U.S. adult population, with many cases going undiagnosed. The associated healthcare costs are substantial, and disease progression often leads to severe cardiovascular complications and kidney failure, necessitating treatments like dialysis or transplantation. Jardiance’s clinically demonstrated benefits offer newfound hope for adults with CKD at risk of progression.

This approval marks the fourth from the FDA for Jardiance, underscoring its significance in addressing cardio-renal-metabolic conditions. With a global enrollment of over 700,000 adults in clinical trials, the EMPOWER program underscores Boehringer Ingelheim and Lilly Alliance’s commitment to enhancing outcomes for individuals facing these conditions. The recent EU approval for Jardiance in CKD further strengthens their global efforts to support this community.

Jardiance’s expanded indications now provide physicians, including nephrologists, with a crucial treatment option for CKD patients at risk of progression, following previous approvals for heart failure and type 2 diabetes. This development is a promising step forward in improving the lives of those affected by CKD.

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