Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receives the US FDA’s Fast Track Designation for Chronic Kidney Disease

Shots:

• The FDA’s FT designation follows EMPA-KIDNEY study assessing Jardiance (10mg, qd) vs PBO in ~6000 patients with CKD. The study was initiated based on the results of EMPA-REG OUTCOME study which showed the 39% reduction in the risk of new-onset and worsening kidney disease in patients with T2D
• The ongoing EMPA-KIDNEY study is evaluating the effect of Jardiance on the progression of kidney disease and the occurrence of CV death in adults with established CKD with/without diabetes
• Jardiance is an oral therapy used to lower the blood sugar level in adults with T2D and CV diseases and is contraindicated in patients with T1D and diabetic ketoacidosis

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