• The positive CHMP opinion is based on the landmark EMPA-KIDNEY trial, the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease (CKD) to date^1,2,3

• When approved, Jardiance^® (empagliflozin) could advance the standard of care for more than 47 million people in the EU living with CKD and other interconnected cardio-renal-metabolic conditions⁴

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance^® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.¹ Empagliflozin is currently indicated for the treatment of heart failure and type 2 diabetes in adults.⁵ When approved, empagliflozin’s indications in the EU will include adults living with CKD, paving the way for an approach to managing the amplified risks of interconnected cardio-renal-metabolic conditions.

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“EMPA-KIDNEY, the trial upon which the CHMP recommendation is based, demonstrated clear benefits on its primary outcome based on kidney disease progression and cardiovascular death in a broad range of adults with chronic kidney disease,” said Professor William Herrington, Clinician Scientist at the Medical Research Council Population Health Research Unit at the University of Oxford, UK, and EMPA-KIDNEY trial Co-Principal Investigator. “The approval of empagliflozin should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,” added Co-Principal Investigator Professor Richard Haynes.

The EMPA-KIDNEY Phase III trial included 6,609 adults across the spectrum of CKD severity with a wide range of underlying causes and co-morbidities, making EMPA-KIDNEY the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date. Empagliflozin demonstrated a significant kidney and cardiovascular benefit in adults with CKD, reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent versus placebo.^2,3

“Across the EU, more than 47 million people are living with chronic kidney disease and even more with cardio-renal-metabolic conditions,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “We are very excited about the potential for empagliflozin to play a key role in the management of these interconnected cardio-renal-metabolic conditions.”

“Cardio-renal-metabolic conditions, like chronic kidney disease, type 2 diabetes and heart failure, are a leading cause of death in Europe. We will continue working closely with regulators worldwide so that adults living with chronic kidney disease, and their health care providers, can benefit from empagliflozin as quickly as possible,” continued Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly.

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About EMPA-KIDNEY: The study of heart and kidney protection with empagliflozin^2,3,6

EMPA-KIDNEY (NCT03594110) is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either 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 <10 mL/min/1.73 m², kidney death, or a sustained decline of ≥40 percent in eGFR from randomization. Key secondary outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality. EMPA-KIDNEY includes 6,609 adults randomized from eight countries with established chronic kidney disease both with and without diabetes, as well as with and without albuminuria, receiving either empagliflozin 10 mg or placebo, on top of current standard of care.

About chronic kidney disease

Chronic kidney disease affects approximately 850 million people worldwide which is more than 10 percent of the population.⁷ The condition is caused by progressive damage to the kidneys that prevents them from working as well as they should. With it mostly being asymptomatic (no symptoms) until later stages of the condition, most people go undiagnosed and every year millions die prematurely from chronic kidney disease and related complications.^6,8,9 The Boehringer Ingelheim and Lilly Alliance are committed to transforming care for people with chronic kidney disease and other cardio-renal-metabolic conditions.

About cardio-renal-metabolic conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than 1.4 billion people worldwide and are a leading cause of death.^10,11

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improvements in one system can lead to positive effects throughout the others.^12,13,14

Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

About empagliflozin

Empagliflozin (marketed as Jardiance^®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.^15,16

Boehringer Ingelheim and Eli Lilly and Company

The Boehringer Ingelheim and Lilly Alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate their commitment, not only to the care of people with type 2 diabetes, but also to address areas of unmet medical need like heart failure and chronic kidney disease.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.

About Lilly

Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visitlilly.com and lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn.

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 Jardiance^® as a treatment for adults with heart failure 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 Jardiance^® 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.

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