13 March 2020 - - The US Food and Drug Administration 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, German drugmaker Boehringer Ingelheim and US-based Eli Lilly and Company (NYSE: LLY) said.

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 associated with an increased risk of premature death from cardiovascular causes and is one of the leading causes of death globally.

About two-thirds of cases are attributed to metabolic conditions such as diabetes (known as diabetic kidney disease), hypertension and obesity.

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% in adults with type 2 diabetes and established cardiovascular disease, compared with placebo.

EMPA-KIDNEY is being independently conducted, analysed 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, in partnership with the Duke Clinical Research Institute.

Boehringer Ingelheim and Lilly are providing the 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.

The FDA fast track is a process designed to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need, defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

The purpose is to get important new medicines to the patient earlier.

A medicine that receives Fast Track designation may receive more frequent communication with the FDA to discuss the medicine's development plan, as well as eligibility for accelerated approval and priority review, if relevant criteria are met.

EMPA-KIDNEY (NCT03594110) is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of empagliflozin on clinically relevant outcomes: kidney disease progression and cardiovascular mortality risk.

The primary outcome is defined as time to a first event of either a cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as, dialysis or kidney transplantation), a sustained decline in eGFR to