Business Wire

Empagliflozin receives Breakthrough Therapy Designation in U.S. for heart failure with preserved ejection fraction (HFpEF)

Share

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for empagliflozin as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. This follows results from the Phase III EMPEROR-Preserved trial which investigated the composite endpoint of cardiovascular death or hospitalization for heart failure in patients with HFpEF.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005550/en/

“We are pleased that the FDA has recognized empagliflozin as a Breakthrough Therapy so soon after the publication of the EMPEROR-Preserved clinical trial results in HFpEF,” commented Ivan Blanarik, Head of Therapeutic Area CardioMetabolism & Respiratory, Boehringer Ingelheim. “Breakthrough Therapy Designation is testament to our commitment to the goal of improving outcomes for people affected by diseases across the cardio-renal-metabolic spectrum.”

HFpEF has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the previous absence of clinically proven therapies.2,3 A leading cause of hospitalization in the U.S. and Europe, its prevalence is increasing and is estimated to affect approximately 30 million people worldwide – about half of all cases of heart failure.4,5

Breakthrough designation is given to treatments of serious or life-threatening conditions where preliminary evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints compared to existing therapies.

The EMPEROR-Preserved Phase III trial results were presented during a hotline session of the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in The New England Journal of Medicine.

Empagliflozin is currently indicated for the treatment of adults with insufficiently controlled type 2 diabetes.6,7,8 Additionally, empagliflozin is approved for the treatment of adults with heart failure with reduced ejection fraction (HFrEF), with or without diabetes, in the European Union and the U.S.6,9 Boehringer Ingelheim and Lilly Alliance plan for global regulatory submissions in HFpEF in 2021.

# Ends #

About the EMPEROR heart failure studies 10,11
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies were two Phase III, randomized, double-blind trials that investigated once-daily empagliflozin compared to placebo in adults with chronic HFrEF or HFpEF, with or without diabetes:

  • EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic HFrEF.
  • Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
  • Number of patients: 3,730
  • Completion: 2020
  • EMPEROR-Preserved [NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF.
  • Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
  • Number of patients: 5,988
  • Completion: 2021

About the EMPOWER program
The Boehringer Ingelheim and Lilly Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.12 Through the EMPOWER program, the Alliance is working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 400,000 adults enrolled worldwide in clinical studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.

About heart failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood.13 To do so, it requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.14 It is a common condition affecting over 60 million people worldwide and expected to increase as the population ages.4,5 Heart failure is highly prevalent in people with diabetes; 15 however, more than half of all people with heart failure do not have diabetes.16

There are different types of heart failure. People with left-sided heart failure have either a reduced or a preserved ejection fraction. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction.17 When the heart relaxes, the ventricle refills with blood.

  • Heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out to the body.17
  • Heart failure with reduced ejection fraction occurs when the left ventricle of the heart is not able to contract effectively, which means that the heart cannot pump with enough force, so less blood is pushed out to the body.17

People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.18 Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.19

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 one billion people worldwide and are a leading cause of death.5,12

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.20,21,22

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.6,7,8

Please click on the following link for ‘Notes to Editors’ and ‘References’ http://www.boehringer-ingelheim.com/press-release/fda-hfpef-breakthrough-designation-emperor-preserved

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172 209

Anna Bergmann
Global Business Communications
Eli Lilly and Company
Email: anna.bergmann@lilly.com
Phone: +1 317 864 3143

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Element Six Launches DNV-B14 a New Grade of Diamond for Quantum Technology Applications21.9.2021 02:01:00 EEST | Press release

Element Six, part of the De Beers Group, has launched DNV-B14™, its newest general-purpose chemical vapour deposition (CVD) quantum-grade diamond, an ideal material for quantum technologies such as magnetic field devices, RF sensors, solid-state gyroscopes and room temperature masers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210920005612/en/ Element Six Launches DNV-B14 a New Grade of Diamond for Quantum Technology Applications (Graphic: Business Wire) The latest solution in Element Six’s DNV™ Series, DNV-B14™ expands the company’s range of advanced materials for emerging quantum technologies. Diamond containing nitrogen-vacancy (NV) centres offers researchers a unique solid-state platform with spin qubits that can be initialised and read out at room temperature, with long qubit lifetimes. These properties stem from diamond’s unique structure and strong bonds. DNV-B14™ is designed to provide the end-user with a uniform

Bentley Systems Announces Finalists for the 2021 Going Digital Awards in Infrastructure20.9.2021 23:02:00 EEST | Press release

Bentley Systems, Incorporated (Nasdaq:BSY), the infrastructure engineering software company, today announced the finalists for the 2021 Going Digital Awards in Infrastructure. The annual awards program honors the extraordinary work of Bentley software users advancing infrastructure design, construction, and operations throughout the world. Sixteen independent jury panels selected the 57 finalists from nearly 300 nominations submitted by more than 230 organizations from 45 countries encompassing 19 categories. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210920005860/en/ Join us for the Year in Infrastructure series of events and Going Digital Awards in Infrastructure highlighting advancements in going digital. (Graphic: Business Wire) Winners of the student Future Infrastructure Star Challenge will also be announced. This challenge provided students from around the world a platform to develop a concept or an idea of how th

New Conviva Data Reveals How Consumers Discover Streaming Content – And the Implications for Publishers20.9.2021 19:55:00 EEST | Press release

Conviva, the intelligence cloud for streaming media, released its State of Streaming: Content Discovery report for 2021 today, revealing how consumers find new streaming content to watch. The report showed content streamed for the first time was discovered in four ways: word of mouth (59%), advertising (52%), social media (49%) and streaming service recommendations (43%). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210920005788/en/ Conviva's State of Streaming Content Discovery (Graphic: Business Wire) “Given the incredible amount of streaming content available today, connecting viewers with content that not only piques their interest, but also resonates enough to keep them coming back for more is a significant challenge for publishers looking to identify and engage new audiences,” said Keith Zubchevich, CEO, Conviva. “By leveraging advertising, recommendations and social media to curate and promote their offerings, publi

Verimatrix To Debut New App Monitoring SaaS Service at Money 20/20 Europe20.9.2021 18:45:00 EEST | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX) (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced it’s scheduled to unveil a new mobile application monitoring service, an extension of its award-winning App Shield and Code Protection solutions, during this week’s Money 20/20 Europe in-person event. Taking place September 21-23 in booth D140 at RAI Amsterdam, Verimatrix’s launch of its security monitoring service for mobile applications can assist both new and existing customers in gaining the intelligence and protections needed for mission-critical apps. The new monitoring solution is available for both Verimatrix App Shield and Verimatrix Code Protection. App Shield is a no-code SaaS service that brings unprecedented cybersecurity protection to any Android or iOS app. Developers simply upload their app to the Verimatrix App Shield platform and receive a secured version that’s ready to publish to an app store, a critical las

Citi, IFC and Global Bank Partner to Finance Women’s Economic Empowerment in Panama20.9.2021 17:08:00 EEST | Press release

Citi, Global Bank and the International Finance Corporation (IFC) have partnered to provide more mortgages and Small Medium Enterprise (SME) business loans to women. The joint initiative offers a first-of-its-kind co-lending transaction of a $90 million loan ($20 million funded by Citi for three years and $70 million funded by IFC for five years) to Global Bank. The proceeds from this loan will be used for either Low Income Housing Mortgages–Hipoteca Preferencial–for women as heads of household or for women-owned and-or women-led enterprises. In addition, Global Bank will also partner with IFC Advisory Services to further enhance and develop gender-focused products and services in Panama. “It’s an honor to support groups and institutions that seek to broaden women empowerment across the region as well as to place women at the center of Panama’s recovery from the coronavirus pandemic,” said Marcelo Gorrini, Caribbean and Central America Cluster Head and Panama Citi Country Officer. “Thi

EMGA Advises Landmark US$300M Debt Raise for BTG Pactual With DFC20.9.2021 17:00:00 EEST | Press release

Emerging Markets Global Advisory Limited (EMGA), the niche investment bank focused on emerging markets, announces today a landmark Senior Debt capital raise transaction that will allow BTG Pactual to expand its small and medium-sized enterprise (SME) activities in Brazil. The US$300 million debt facility was provided by DFC and the transaction is the largest Senior Debt facility ever advised by EMGA and follows on from a US$140 million transaction completed last year with DEG and Proparco, two European development institutions. The operation comes at a time when banks world-wide are exploring new cross-border funding options to further deliver on their support to businesses affected by the COVID-19 pandemic. Commenting on the transaction, BTG Pactual’s Caio Zanette said, “BTG Pactual is very pleased with the support of EMGA on pursuing this landmark transaction that will benefit our SME activities in Brazil. We continue to develop all our activities and the funding provided by DFC will

WilsonHCG Recognized as a “Leader” in Contingent Workforce Solutions and MSP by NelsonHall20.9.2021 17:00:00 EEST | Press release

WilsonHCG has been identified as a “Leader” in NelsonHall’s 2021 NEAT Vendor Evaluation and Assessment Tool for Managed Service Program (MSP) and Contingent Workforce Services (CWS) providers. “Being ranked as a Leader for our contingent workforce services is a testament to listening to our clients’ needs and differentiating by providing a high-touch experience that’s often overlooked in this space. The team is committed to exceptional service and it shows,” said John Wilson, CEO, WilsonHCG. “Organizations are looking for a variety of talent solutions in this challenging market and we’re proud to offer contingent workforce services that give them access to the talent they need to succeed.” Nikki Edwards, Principal Research Analyst with NelsonHall’s HR Technology & Services practice, added, “WilsonHCG applies a high-touch and personalized approach to its range of next-generation contingent workforce solutions (with a broad range of service expertise and use of cutting-edge tech), enabli

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom