The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).
Some 37 million people in the U.S. have CKD.
Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim.
The supplemental New Drug Application includes data from the landmark EMPA-KIDNEY Phase 3 study, which found that empagliflozin led to a significant reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD. In the study, the drug on top of standard of care reduced the risk of kidney disease progression or cardiovascular death in adults by 28% compared with placebo.
EMPA-KIDNEY is an abbreviation of Empagliflozin in the Management of Patients with Advanced Chronic Kidney Disease.
The randomized, double-blind, placebo-controlled study (NCT03594110) enroll…