Officials with the FDA have granted Fast Track designation to empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) for the treatment of chronic kidney disease (CKD) in adults, according to a press release.
If approved, empagliflozin will be indicated to reduce the risk of kidney disease progression and cardiovascular (CV) death in adult patients with CKD. Empagliflozin is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce CV death in adults with type 2 diabetes and known CV disease.
The designation is based the ongoing EMPA-KIDNEY clinical trial, which is evaluating the effect of empagliflozin on the progression of kidney disease and the occurrence of CV death in adults with established CKD. The primary outcome of the study is defined as time to a first event of either CV death or kidney disease progression, defined as time to a first even of either CV death or kidney disease progression, defined as end-stage kidney disease, a sustained decline in EGFR to <10 mL/min/1.74 m2, a renal death, or a sustained decline of ≥40% in eGFR from randomization.
Based on the findings, treatment with empagliflozin reduced the risk of new-onset and worsening kidney disease by 39% in adults with type 2 diabetes and established CV disease compared with placebo.
The global trial is aiming to randomize approximately 6000 participants total to receive either empagliflozin 10 mg once daily or placebo, in addition to standard of care.
“We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance,” Jeff Emmick, MD, PhD, vice president of Product Development, Lilly, said in a statement. “The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease.”
1. US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease [news release]. Eli Lilly's website. https://investor.lilly.com/news-releases/news-release-details/us-fda-gra.... Accessed March 17, 2020.