Otolide(R) (empagliflozin) becomes the first and currently only therapy approved in Europe for the treatment of symptomatic adults with chronic heart failure regardless of their ejection fraction

This groundbreaking approval expands the existing indications for Otolide® to include the treatment of adults with heart failure with preserved ejection fraction (HFpEF), a patient population with unmet medical needs, There are no previously approved therapies for this group in Europe 24 February 2022 Otolide® received marketing approval from the U.

Ingelheim, Germany, March 7, 2022 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly & Company announced that the European Commission (EC) has granted marketing authorization for Otanixine® (empagliflozin) for the treatment of symptomatic of adults with chronic heart failure

Heart failure affects more than 15 million people in Europe and results in nearly 2 million hospital admissions each year

“It is estimated that more than 60 million people worldwide suffer from heart failure

The approval is based on results from the ground-breaking EMPEROR-Preserved ® Phase III trial in 5,988 adults with heart failure with an LVEF greater than 40% that explored the use of placebo in addition to standard of care Compared to the efficacy of 10 mg of empagliflozin added once daily

"Today's approval of this indication in Europe will redefine the standard of care for millions of heart failure patients in the EU," said Waheed Jamal, MD, Vice President and Head of Cardiometabolic Medicine, Boehringer Ingelheim

"We are pleased with the EC decision following our recent FDA approval to approve empagliflozin as the first and currently only treatment for adult patients with symptomatic chronic heart failure," Eli Lilly Product Development Vice President Jeff Emmick, MD, said, "This is an important step forward in our efforts to find therapeutic options for patients with a range of cardiorenal metabolic diseases

The EMPEROR-Preserved trial is part of the EMPOWER clinical research program, the most extensive and comprehensive clinical research program of any SGLT2 inhibitor, to explore the impact of empagliflozin on the lives of patients with various cardio-renal-metabolic diseases

About the EMPEROR Heart Failure Study[6],[7]

The EMPEROR (Outcomes Trial of Empagliflozin in Patients with Chronic Heart Failure) The Chronic Heart Failure study consists of two phase III, randomized, double-blind trials in adults with chronic heart failure with preserved and reduced ejection fraction (both Including patients with and without diabetes), on the basis of standard care, to study the efficacy and safety of once-daily empagliflozin compared with placebo:

EMPEROR-Reduced [NCT03057977]: To evaluate the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF)

About the EMPOWER project

The consortium developed the EMPOWER project to explore the effects of empagliflozin on key clinical cardiovascular and renal outcomes across a range of cardio-renal-metabolic diseases

About heart failure

Heart failure is a progressive, debilitating, and potentially fatal disease when the heart cannot supply enough circulation to meet the body's need for oxygenated blood or to increase blood volume causing fluid to build up (congestion) in the lungs and peripheral tissues happen

About Heart-Kidney-Metabolic Disease

Boehringer Ingelheim and Eli Lilly hope to change the way patients are treated for heart-kidney-metabolic disease, a group of interconnected diseases that affect more than a billion people worldwide and are the leading cause of death

The cardiovascular, renal, and metabolic systems are interconnected and share many of the same risk factors and pathological pathways across the disease spectrum

Through our research and treatments, we aim to support people's health, restore balance between the interconnected heart-kidney-metabolic systems, and reduce their risk of serious complications

About Empagliflozin

Empagliflozin (trade name Ou Tangjing) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, and is the first in many countries to include lower cardiovascular Type 2 diabetes medications with mortality risk data

References

[1] Health Policy Partnership.

[2] Andersen MJ, Borlaug BA.
Heart failure with preserved ejection fraction: current understandings and challenges.
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[3] Butler J, Fonarow G, Zile M, et al.
Developing therapies for heart failure with preserved ejection fraction: Current State and Future Directions.
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[4] Shah SJ, Borlaug B, Kitzman D, et al.
Research priorities for heart failure with preserved ejection fraction.
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[5] Anker S, Butler J, Filippatos G, et al.
Empagliflozin in Heart Failure with a Preserved Ejection Fraction.
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[6] ClinicalTrials.
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EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced).
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gov/ct2/show/NCT03057977.
Accessed: February 2022.

[7] ClinicalTrials.
gov.
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved).
Available at: https://clinicaltrials.
gov/ct2/show/NCT03057951.
Accessed: February 2022.

[8] GBD 2015 Mortality and Causes of Death Collaborators.
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[9] American Heart Association.
What is Heart Failure? Available at: https:// Accessed: February 2022.

[10] American Heart Association.
Types of Heart Failure.
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[11] Lippi G, Sanchis-Gomar F.
Global epidemiology and future trends of heart failure.
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[12] Kenny HC, Abel ED.
Heart Failure in Type 2 Diabetes Mellitus.
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[13] Dunlay SM, Givertz MM, Aguilar D, et al.
Type 2 Diabetes Mellitus and Heart Failure: A Scientific Statement From the American Heart Association and the Heart Failure Society of America.
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[14] Thomas M, Cooper M, Zimmet P.
Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease.
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[15] García-Donaire JA, Ruilope LM.
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[16] Leon BM, Maddox TM.
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[17] Jardiance® (empagliflozin) tablets.
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[18] Jardiance® (empagliflozin) tablets, US Prescribing Information.
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Accessed: February 2022.

About Boehringer Ingelheim and Eli Lilly

In January 2011, Boehringer Ingelheim and Eli Lilly announced a cooperation agreement, which includes several varieties of hypoglycemic drugs
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Based on different markets, the two parties will choose to jointly promote or individually promote the drugs provided by each of them for this cooperation
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This collaboration brings together the strengths of two leading global pharmaceutical companies focused on patient needs, and by working together, the two companies are committed to helping people with diabetes and exploring solutions to their unmet medical needs
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Clinical trials evaluating empagliflozin in patients with heart failure or chronic kidney disease have been initiated
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About Boehringer Ingelheim

Boehringer Ingelheim is committed to researching breakthrough treatments aimed at improving human and animal health
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As a leading global biopharmaceutical company driven by research and development, the company delivers value through innovation in areas of high unmet medical need
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Since its founding in 1885, Boehringer Ingelheim has remained an independent family-owned company and this will not change in the long run
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About 52,000 employees serve more than 130 locations worldwide in three business areas: Human Medicines, Animal Health and Biopharmaceutical Contract Manufacturing
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About Eli Lilly and Company

As a global leader in the healthcare industry, Lilly is committed to repaying patients with innovation and caring for life
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For more than 140 years since its establishment, Lilly has always pursued the philosophy of providing patients with the highest quality medicines with the latest technology, which is in line with the commitment of the company's founder, Colonel Lilly
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Today, Lilly remains committed to this mission and conducts its work accordingly
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Lilly people around the world not only devote themselves to the development of life-saving medicines, actively help patients better understand and manage diseases, but also give back to the society through charitable activities
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Source: Boehringer Ingelheim