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) enrolled more than 6,600 patients.
Empagliflozin belongs to a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which prevent kidneys from reabsorbing glucose back into the bloodstream. Empagliflozin thus causes patients to excrete extra glucose in the urine.
The reduction in blood sugar levels may also slow the progression of kidney disease. Empagliflozin also could help the body remove excess fluid and electrolytes, which can help people with CKD reduce the volume of fluid in the body and decrease kidney workload.
FDA first approved empagliflozin to treat type 2 diabetes in 2014. Indications followed for reducing cardiovascular death in adults with type 2 diabetes, treating adults with heart failure with reduced ejection fraction and heart failure regardless of left ventricular ejection fraction.
In the EMPA-KIDNEY study, the safety data for empagliflozin was in line with prior studies.
Empagliflozin won FDA Fast Track designation in March 2020 to lower the risk of kidney disease progression and cardiovascular death in adults with CKD.
This study was a randomized, double-blind, placebo-controlled trial that enrolled over 3000 participants with stages 3b to 4 CKD and type 2 diabetes.