Eli Lilly Announces FDA Acceptance Of SNDA For Jardiance For Chronic Kidney Disease

Eli Lilly and Co. (LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. announced on Friday that FDA accepted a supplemental new drug application for Jardiance or empagliflozin tablets for adults with chronic kidney disease. The sNDA is based on reduced risk of kidney disease progression or cardiovascular death in the double-blind, multinational, placebo-controlled phase III trial EMPA- Kidney.

Earlier in March 2020, the Jardiance trial received fast-track designation to reduce kidney disease progression and cardiovascular death in adults with chronic kidney disease or CKD.

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