U.S. FDA grants Fast Track designation to empagliflozin for the treatment of chronic kidney disease
Ingelheim, Germany, and Indianapolis,
Ingelheim, Germany, and Indianapolis, U.S., 12 March, 2020 – 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 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 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
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centres on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance® on people living with heart failure or chronic kidney disease.
Boehringer Ingelheim
Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.
Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of nearly 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 percent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions – from medicines to support programmes and more – we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at http://www.lilly.com/ and https://newsroom.lilly.com/social-channels.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about clinical trials to evaluate empagliflozin as a treatment for adults with chronic kidney disease and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that empagliflozin will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
CONTACT:
Dr Petra Kienle
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
Stephan Thalen
Global Business Communications
Lilly Diabetes and Lilly USA
Email: stephan.thalen@lilly.com
Phone: (317) 903-564
References
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2 Levin A, Tonelli M, Bonventre J, et al. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet 2017;390:1888-917.
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8 American Kidney Fund. Kidney Failure (ESRD) Causes, Symptos, & Treatments. Available at: http://www.kidneyfund.org/kidney-disease/kidney-failure/. Accessed March 2020.
9 Wang H et al. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet 2016; 388(10053):1459–544.
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11 Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed March 2020.
12 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
13 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.
14 Vallon V and Thompson SC. Targeting renal glucose reabsorption to treat hyperglycaemia: the pleiotropic effects of SGLT2 inhibition. Diabetologia 2017;60(2):215-25.
