Business Wire

Jardiance® (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction

Share

The European Commission has granted marketing authorization for Jardiance® (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure), Boehringer Ingelheim and Eli Lilly and Company have announced. The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021.2

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210621005298/en/

“Today’s approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and more time with their families.”

Marketing authorization is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization due to heart failure.3 The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.3

“Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status. We look forward to collaborating with regulators in Europe and beyond to ensure access to this trusted therapy.”

“As we enter this new chapter of heart failure management, we can now look ahead to results from the EMPEROR-Preserved trial, expected this year. This trial will explore empagliflozin in heart failure with preserved ejection fraction, in adults with or without diabetes,” continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We are committed to finding solutions for the millions of people who live with heart failure and important metabolic conditions around the world.”

Heart failure is often associated with other diseases of the cardio-renal-metabolic systems such as type 2 diabetes and kidney disease. Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others. Heart failure is a very common and severe complication of a heart attack4,5 and occurs when the heart cannot pump sufficient blood to the rest of the body. There are two forms of the condition; heart failure with reduced ejection fraction means the heart cannot contract normally, while preserved ejection fraction means the heart cannot properly fill with blood. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.6,7

The EMPEROR-Reduced trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.

+++

About the EMPEROR Heart Failure Studies8,9
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, with or without diabetes, who are receiving current standard of care:

  • EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
  • Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
  • Number of patients: 3,730
  • Completion: 2020
  • Link to lay summary
  • EMPEROR-Preserved [NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (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 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.10 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of eight 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 studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program 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, or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.4 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes;11 however, approximately half of all people with heart failure do not have diabetes.12

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.10

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, improving the health of one system can lead to positive effects throughout the others.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.15,16,17

Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/reduced-heart-failure-treatment-approval-europe

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 172209

Greg Kueterman
Senior Director of Communications
Eli Lilly and Company
Email: kueterman_gregory_andrew@lilly.com
Phone: +1-317-432-5195

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

Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 09:32:00 EEST | Press release

Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation

Takeda Delivers Solid First Quarter FY2021 Results, Positioning Company to Accelerate Topline Growth and Continued Pipeline Progress30.7.2021 09:00:00 EEST | Press release

Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) (“Takeda”) today announced financial results for the first quarter of fiscal year 2021 (period ended June 30, 2021). Based on the solid first-quarter results, the Company also confirmed its fiscal year 2021 management guidance and forecast. Fiscal year 2021 remains a year of inflection with Takeda positioned for topline acceleration and continued pipeline progress, including critical regulatory submissions, potential approvals and additional new molecular entities (NMEs) advancing in pivotal studies. Costa Saroukos, Chief Financial Officer, commented: “With the Shire integration behind us and continued transformation over the last two years, we’ve pivoted towards accelerating topline growth and investing in R&D to fuel our highly innovative pipeline. Takeda’s first-quarter results demonstrate the continued strength of our 14 global brands and, with the business momentum from this strong start to our fiscal year, we remain on t

Conviva and the Trade Desk Partner to Improve Contextual Advertising for Premium Streaming Publishers29.7.2021 20:04:00 EEST | Press release

Conviva, the intelligence cloud for streaming media, and global advertising technology leader The Trade Desk, have entered a first-of-its-kind partnership to provide the streaming advertising industry the contextual content signals needed in the bidstream to improve their connected TV campaigns based on signals and effectiveness. Together, the two companies will help premium publishers supply programmatic buyers with the network, genre, rating, length and other detailed data sorely lacking in the streaming industry while still maintaining data control. Details of the partnership, product offering, participating publishers and how premium publishers can participate and benefit, will be available via a webinar in August. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005953/en/ The Trade Desk + Conviva (Graphic: Business Wire) According to Conviva’s State of Streaming Advertising report, released in June 2021, only 39% o

New Harris Poll: Cybersecurity Fears May Stall COVID-19 Digital Vaccine Card Adoption in the United Kingdom, Identity Theft and Fake Cards Top List of Concerns29.7.2021 18:02:00 EEST | Press release

Anomali, the leader in intelligence-driven cybersecurity solutions, today announced availability of its latest survey conducted by The Harris Poll. The study, which gathered responses from more than 1,000 adults aged 18 and over in the United Kingdom, reveals that more than three-quarters of British adults have cybersecurity fears around the use of COVID-19 digital vaccination cards. Additional findings showed which entities respondents believe are responsible for protecting them against cyberattacks and who they believe the most likely culprits will be. A majority of respondents predict that a disruptive cyberattack will follow digital vaccine card adoption, findings also reveal confidence levels when it comes to how prepared the nation is to mount a defense. Among key findings: 76% have cybersecurity concerns related to COVID-19 digital vaccination cards. Identity theft topped the list at 51%, with fake vaccine cards that could be used to hack smartphones (44%) and data breaches (45%

QuadraGen Announces the Launch of Its Next Generation Commercial Loan Processing SaaS Platform and Edward Ho Joins As Chairman29.7.2021 17:00:00 EEST | Press release

QuadraGen announces the launch of its next generation commercial loan servicing SaaS platform to help financial institutions transform their complex loan processing capabilities. The QuadraGen Platform supports various areas of loan operations, enabling more efficient and effective processing of loan information, risk management, and decision-making. The QuadraGen SaaS platform consists of a suite of independently deployable microservices that augment existing technology, filling in gaps where processes and functions are not well executed, or replacing legacy capabilities with its next generation software. QuadraGen’s key differentiator is its team of experts, who have decades of commercial lending experience understanding and solving complex loan operation issues. Financial institutions are challenged by the size, complexity, number of participants, and speed of the loan markets. Many institutions use in-house or legacy systems that are inadequate for today’s ever-growing needs. Quadr

Comcast Announces Peacock Coming to Sky29.7.2021 16:30:00 EEST | Press release

Comcast today announced NBCUniversal and Sky will make Peacock available at no additional cost to nearly 20 million Sky customers in Europe. Beginning later this year, Peacock will make its international debut across Sky platforms, including Sky Q, NOW, and Sky Ticket, currently serving customers throughout the UK, Ireland, Germany, Italy, Austria, and Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005660/en/ “Comcast’s Xfinity has been integral to the success of our go-to-market strategy with Peacock in the U.S., and we see a similar opportunity to expand internationally with Sky,” said Jeff Shell, Chief Executive Officer, NBCUniversal. “We are excited to bring Peacock to millions of Sky customers and add incredible value to their platforms with a premium catalog of the best entertainment from across NBCUniversal that is included with their subscription. By leveraging Comcast’s Xfinity platforms in the U.

BOW Group Acquires Musart, Adding Innovative Art Marketplace to Its Offering29.7.2021 16:15:00 EEST | Press release

BOW Group today announced that it has successfully completed the acquisition of Musart.com, a fast-growing online destination to buy original artworks and licensed products. This transaction will allow BOW Group to seize new opportunities in the booming digital art market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005637/en/ (Photo: Musart) “BOW Group and Musart share the same passion for good yet accessible design that brings emotions to consumers at every moment of the day,” said Boris Brault, BOW Group Founder and CEO. “Together, with Musart’s unique product curation and established relationships with leading institutions, we can conquer the thriving online art market thanks to our global ecommerce, logistics and development capabilities. With Musart in our portfolio, we are expanding our offering and enhancing the growth potential of our business beyond IoT and lifestyle objects. Today, the art world is fundam

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