U.S. FDA grants Fast

INGELHEIM, Germany, and INDIANAPOLIS, Ind.--(BUSINESS WIRE)--The U.S. 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.1

“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 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.

About FDA Fast Track

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.

About EMPA-KIDNEY [NCT03594110]

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 <10mL/min/1.73m2, renal death or a sustained decline of ≥40 percent in eGFR from randomization. EMPA-KIDNEY is expected to include about 6,000 people with established chronic kidney disease both with and without diabetes, as well as with and without proteinuria, receiving either empagliflozin 10 mg or placebo, on top of current standard of care.

About Chronic Kidney Disease

Chronic kidney disease is defined as a progressive decline of kidney function over time. About two-thirds of chronic kidney disease cases are attributable to metabolic conditions such as diabetes (known as diabetic kidney disease), obesity and hypertension.2,3,4

Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end-stage kidney disease.5,6,7 Once end-stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.8 Chronic kidney disease is highly prevalent in various parts of the world, affecting more than nine percent of the population.1 Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options in people with chronic kidney disease is evident.

About Cardiorenal Metabolic Conditions

Cardio, renal and metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually.9 Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.10

Emerging science on the link between the cardio, renal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. A team approach to optimize patient care by coordinating treatment of related comorbidities, including the use of emerging medications with broad cardio, renal and metabolic effects, may improve outcomes for people with serious chronic conditions such as these.

Boehringer Ingelheim and Lilly are committed to advancing treatments and pioneering research to address the public health challenges of cardio, renal and metabolic conditions, including cardiovascular disease, chronic kidney disease and type 2 diabetes.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first medicine approved by regulatory authorities to significantly reduce the risk of cardiovascular death or include data on the reduction of the risk of cardiovascular death in the label for adults with type 2 diabetes and established cardiovascular diaease.11,12,13

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.14