US FDA grants Fast Track designation to empagliflozin for the treatment of chronic kidney disease


THE US Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The designation was granted for the clinical investigation of empagliflozin in adults with chronic kidney disease.

This Fast Track designation for empagliflozin underscores the urgent need for new treatment options for people living with chronic kidney disease worldwide, many of whom are at risk of progressing to end-stage kidney disease.

“Chronic kidney disease is a serious and highly prevalent condition, which affects nearly 700 million adults worldwide,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.

“This decision from the FDA demonstrates how important effective treatment options are for people with chronic kidney disease and the cardiovascular and metabolic disorders it is linked to.”

Chronic kidney disease is associated with an increased risk of premature death from cardiovascular causes and is one of the leading causes of death globally. 1 About two-thirds of cases are attributed to metabolic conditions such as diabetes (known as diabetic kidney disease), hypertension and obesity. 2,3,4

“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 empagliflozin,” said Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly. “The Fast Track designation from the FDA is an important step in evaluating the potential of empagliflozin to enhance care for those with chronic kidney disease.”

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.

The EMPA-KIDNEY study was initiated based on promising exploratory results from the landmark EMPA-REG OUTCOME trial, which 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 being independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), in partnership with the Duke Clinical Research Institute (DCRI). Boehringer Ingelheim and Lilly are providing funding for the study.

This most recent decision follows a Fast Track designation which was granted by the FDA in July 2019 for the investigation of empagliflozin to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.

– Mar. 12, 2020 @ 18:55 GMT |

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