US FDA fast tracks empagliflozin to treat chronic kidney disease

US FDA fast tracks empagliflozin to treat chronic kidney disease

The US FDA has granted Fast Track designation for the investigation of empagliflozin (Jardiance) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Eli Lilly and Boehringer Ingelheim have announced.

The ongoing EMPA-KIDNEY clinical study is evaluating the effect of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes.

Earlier, EMPA-REG OUTCOME trial found that treatment with empagliflozin reduced the risk of new-onset and worsening kidney disease by 39 percent in adults with type 2 diabetes and established cardiovascular disease compared with placebo.

EMPA-KIDNEY is a multinational randomized, double-blind, placebo-controlled clinical trial. It is designed to evaluate the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either cardiovascular death or kidney disease progression, defined as end-stage kidney disease, a sustained decline in eGFR to <10 mL/min/1.73 m2, renal death, or a sustained decline of =40% in eGFR from randomization. EMPA-KIDNEY includes adults with established chronic kidney disease both with and without diabetes.

The study is a global trial aiming to randomize about 6,000 participants to receive either empagliflozin 10 mg once daily or placebo, each on top of standard of care.

Empagliflozin is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

In June 2019, the FDA granted Fast Track designation to the clinical investigation of empagliflozin to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

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