US FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction

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Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced

Jardiance 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 <30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.

Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

“Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical,” said Javed Butler, M.D., Chairman, Department of Medicine, University of Mississippi. “Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction.”

HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.

This approval for Jardiance is based on results from the EMPEROR-Reduced phase III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40% or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% (5.3% absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI) versus placebo. These results were seen regardless of background heart failure standard of care treatments.

A key secondary endpoint analysis from EMPEROR-Reduced demonstrated that Jardiance helped keep patients out of the hospital by significantly reducing the relative risk of first and recurrent hospitalization for heart failure by 30% (388 events for Jardiance vs. 553 for placebo, 0.70 HR, 0.58-0.85 95% CI). The safety profile was consistent with the well-established safety profile of Jardiance.

Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients of Jardiance as reactions such as angioedema have occurred and is contraindicated in patients on dialysis. Please see additional Important Safety Information below.

“Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalization for heart failure,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing risk of cardiovascular death and hospitalization for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care. Today’s FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorization for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure. We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions.”

“Today’s approval is significant for the millions of people diagnosed with this form of heart failure, offering additional hope for those who have seen limited new treatment options over the last decade,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “Following EMPA-REG OUTCOME®, this is the second U.S. regulatory decision stemming from the EMPOWER clinical trial program, which is exploring the impact of Jardiance on major clinical cardiovascular outcomes. Jardiance is already a recognized leader for adults with type 2 diabetes, including those who also have established cardiovascular disease. We’re excited to build on that legacy with this new indication that establishes Jardiance as an effective treatment for adults with heart failure with reduced ejection fraction – regardless of whether they have type 2 diabetes.”

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 Jardiance on people living with heart failure or chronic kidney disease.

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, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more.

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