- Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
- FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”1,2
- Heart failure is a leading cause of hospitalization in the U.S. and Europe. Its prevalence is increasing and is estimated to affect over 60 million people worldwide3,4
The U.S. Food and Drug Administration (FDA) has approved empagliflozin 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.
Empagliflozin is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73 m5 as it is likely to be ineffective in this setting based upon its mechanism of action.
Empagliflozin can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.5
“In its phase III trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” said Javed Butler, M.D., chairman, Department of Medicine, University of Mississippi. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.”
Affecting more than 6 million people in the U.S., heart failure is a leading cause of hospitalization and is becoming increasingly prevalent due to the aging population.3,6 Just six months ago, Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for one type of heart failure – heart failure with reduced left ventricular ejection fraction (LVEF). Today’s decision expands this indication to include all adults with heart failure. As a result, the indication now includes adults with preserved LVEF.
Empagliflozin is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, as reactions such as angioedema have occurred, and in patients on dialysis.
“The FDA approval is very welcome news for people living with heart failure in the U.S.
We now look forward to further approvals globally to bring empagliflozin treatment to many more heart failure patients, across the range of their left ventricular ejection fraction,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “The significant clinical benefits seen in the EMPEROR-Preserved clinical trial gives clinicians an opportunity to redefine the way we approach the treatment of heart failure and is a significant step forward in this area of unmet need for patients.”
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.12,13 It is a widespread condition affecting over 15 million people in Europe14 and over 60 million people worldwide and expected to increase as the population ages.4,15 Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.16
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.5,20
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of empagliflozin on people living with heart failure or chronic kidney disease.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that 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.