Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline, kidney failure, cardiovascular death, and hospitalization in adults with CKD at risk of progression, a condition that affects an estimated 35 million individuals in the United States.
Phase III Study Results and FDA Decision
The FDA’s decision is based on the results of a placebo-controlled Phase III study, which demonstrated that Jardiance reduced the risk of kidney disease progression or cardiovascular death by 3.6% per patient-year at risk. This clinical evidence supports the drug’s efficacy in managing CKD and its potential to improve patient outcomes.
Previous Approvals and Expanded Indications
Jardiance has previously been approved by the FDA for the treatment of heart failure and type 2 diabetes (T2D). The expansion of its indications to include CKD prevention further solidifies the drug’s role in addressing multiple health concerns and underscores the importance of SGLT2 inhibitors in the management of chronic conditions.-Fineline Info & Tech
