US FDA grants Fast Track designation to empagliflozin for the treatment of chronic heart failure

  • Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need. 
  • FDA’s Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the 26 million people affected by chronic heart failure worldwide, including 6.5 million in the US.1,2
 
Ingelheim, Germany, and Indianapolis, US, 26 June 2019 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure. The Fast Track designation facilitates the development of new therapies that fill an unmet medical need for serious conditions in an effort to expedite the availability of new treatment options.
 
This designation is for the ongoing EMPEROR programme, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of empagliflozin on cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction (HFrEF or HFpEF, respectively). 
 
“Heart failure is a leading cause of hospitalisation, with more than one million admissions annually just in the US and Europe. Yet, there are limited treatment options for people living with this debilitating condition,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “The FDA Fast Track designation for empagliflozin is an important step forward in addressing this unmet need in the US, and we look forward to working closely with the FDA as we explore the potential for empagliflozin to improve outcomes for adults with chronic heart failure.”
 
“Boehringer Ingelheim and Lilly are committed to advancing treatments that address public health challenges of cardiometabolic diseases, including chronic heart failure,” said Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly. “We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting.”
 
The two EMPEROR Phase III studies include more than 8,500 people with chronic heart failure, and are designed to assess the effect of treatment with empagliflozin on cardiovascular death and hospitalisation for chronic heart failure as primary endpoints. The EMPEROR studies are part of the empagliflozin chronic heart failure programme.3,4
 
About the Empagliflozin Chronic Heart Failure Programme
The empagliflozin chronic heart failure programme consists of the EMPEROR-Preserved and EMPEROR-Reduced studies, the EMPERIAL-Preserved and EMPERIAL-Reduced studies and the EMPA-VISION study. These studies are evaluating the efficacy and safety of empagliflozin in more than 9,000 adults with chronic heart failure, including those with and without diabetes.3,4,5,6,7
 
About the EMPEROR Chronic Heart Failure Studies3,4
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two Phase III, randomised, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved ejection fraction and adults with heart failure with reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
 
  • EMPEROR-Preserved [NCT03057951]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
    • o Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure (HHF) [Time Frame: up to 38 months]
    • o Anticipated number of patients: approx. 5,250
    • o Estimated completion: 2020
       
  • EMPEROR-Reduced [NCT03057977]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
    • o Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated HHF [Time Frame: up to 38 months]
    • o Anticipated number of patients: approx. 3,600
    • o Estimated completion: 2020
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply enough blood around the body.8 It is a prevalent disease, affecting 26 million people worldwide, and this is expected to increase as the population ages.1 Heart failure is highly prevalent in people with diabetes;9 however, approximately half of all people with heart failure do not have diabetes.1,10
 
 
Symptoms of heart failure include difficulty breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others.11 People with heart failure experience a substantial reduction in quality of life, with approximately 76 percent finding it difficult to carry out usual activities.12 This is, in part, due to limitation of physical activity. 
 
There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years.13 Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the US and Europe.1 
 
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 the label in several countries.14,15,16
 
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces 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.
 
About Boehringer Ingelheim and Eli Lilly and Company 
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.
 
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 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 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 
Phone: +49 (6132) 77 143877
 
Stephan Thalen
Global Business Communications
Lilly Diabetes 
Phone: +1 (317) 276 8304 

Footnotes

*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared with a normally functioning heart.

 

References

1 Ambrosy AP, Fonarow GC, Butler J, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014;63(12)1123-33.
2  Benjamin EJ, Virani SS, Callaway CW, et al.: Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492.
3 ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03057977?term=emperor&rank=1. Accessed May 2019.
4 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?term=emperor&rank=2. Accessed May 2019.
5 ClinicalTrials.gov. A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL – reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03448419?term=EMPERIAL&rank=2. Accessed May 2019.
6 ClinicalTrials.gov. A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF) (EMPERIAL – preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03448406?term=EMPERIAL&rank=1. Accessed May 2019.
7 ClinicalTrials.gov. A Study That Looks at the Function of the Heart in Patients With Heart Failure Who Take Empagliflozin (EMPA-VISION). Available at: https://clinicaltrials.gov/ct2/show/NCT03332212. Accessed May 2019.
8 American Heart Association. What is Heart Failure? Available at: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure. Accessed May 2019.
9 Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;128(16):e240-e327.
10 Suskin N, McKelvie RS, Burns RJ, et al. Glucose and insulin abnormalities relate to functional capacity in patients with congestive heart failure. Eur Heart J 2000;21:1368-75.
11 Watson RDS, Gibbs CR, Lip GYH. Clinical features and complications. BMJ. 2000;320(7229):236-39.
12  Calvert MJ, Freemantle N and Cleland JG. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Eur J Heart Fail. 2005;7(2):243-51.
13 Ponikowski P, Anker SG, AlHabib KF, et al. Heart failure: Preventing disease and death worldwide. ESC Heart Fail. 2014;1(1):4-25.
14 Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Accessed May 2019. 
15 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.
16 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.

 

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