CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction

 – The positive opinion is based on the landmark EMPEROR-Preserved Phase III trial, which showed significant outcomes in patients with heart failure with left ventricular ejection fraction over 40%¹

– If approved, Jardiance would be the first and only clinically proven treatment approved for all adults with symptomatic chronic heart failure including those with preserved ejection fraction

– Heart failure is a leading cause of hospitalization in Europe.² Its prevalence is increasing, and it is estimated to affect over 60 million people worldwide.³

INGELHEIM, Germany–(BUSINESS WIRE)–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 symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced today.¹ Empagliflozin was previously approved for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).⁴ If approved, the positive opinion would expand this indication to be applicable for adults across the full spectrum of left ventricular ejection fraction (LVEF), including preserved ejection fraction (HFpEF).

“For the very first time, we now have a treatment that will improve clinical results across the full spectrum of heart failure patients – regardless of ejection fraction,” said Professor Stefan Anker, Heart Failure Cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved Principal Investigator. “Half of all heart failure patients are those with a preserved left ventricular ejection fraction. They suffer symptomatically and have poor outcomes due to the absence of any approved beneficial therapies. Today’s positive opinion of EMA is a significant step forward in redefining clinical practice and will provide an additional lifeline to the millions of patients in Europe diagnosed with HFpEF.”

The positive opinion is based on results from the landmark EMPEROR-Preserved Phase III trial, which investigated the effect of empagliflozin 10 mg compared with placebo once-daily, both added to standard of care, in 5,988 adults with heart failure with LVEF over 40%.⁵ In the trial, empagliflozin demonstrated an impressive 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. The benefit was regardless of ejection fraction or diabetes status.⁵

“We are delighted with the CHMP’s decision to recommend empagliflozin as a treatment for adults with chronic heart failure,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Understanding of the interconnected cardio, renal and metabolic systems enabled us to broaden from diabetes to heart failure, following the science to provide solutions to medicine’s greatest challenge. We are proud to provide renewed hope to underserved patients, underscored by the unprecedented clinical benefit seen in the EMPEROR-Preserved clinical trial.”

“Today’s positive opinion addresses the single largest unmet need in cardiovascular medicine, confirming the potential of empagliflozin across the full spectrum of ejection fraction. We are committed to ongoing research in these underserved areas, and look forward to the results from the EMPA-KIDNEY trial, exploring the potential of empagliflozin in chronic kidney disease,” continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly.

The EMPEROR-Preserved 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.

# ENDS #

About the EMPEROR heart failure clinical trials^6,7

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure trials 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 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.⁸ 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 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 trials, 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, or to do so, requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.^9,10 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages. ^3,11 Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.^12,13

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.^11,14

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. ^14,15,16

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.^17,18

Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/human-health/heart-diseases/heart-failure/emperor-preserved-chmp-positive-opinion

Contacts

Stefanie Molkenthin
Boehringer Ingelheim

Email: [email protected]
Phone: +49 (6132) 77 172 209

Stephan Thalen
Eli Lilly and Company

Email: [email protected]
Phone: (317) 903-5640