The U.S. Food and Drug Administration (FDA) announced the approval of a new medication for treating heart failure. This new medication will expand the treatment options currently available to doctors to treat heart disease and its effects on the body.

In an effort to expand the treatment options for heart failure, the FDA has approved Boehringer Ingelheim Pharmaceuticals’ drug, Jardiance (empagliflozin), to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. 

Jardiance has been on the market for some time, originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance may prove very helpful to diabetic adults because, according to the CDC, people living with diabetes are twice as likely to develop heart disease.

Norman Stockbridge, M.D., Ph.D., Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research said, “Today’s approval will provide a treatment option for a wider range of patients with heart failure.” 

Since Jardiance was originally approved to treat type 2 diabetes, its applicability has been limited to being prescribed in order to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Dr. Stockbridge said, “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure.” 

Before the FDA gave their approval for this new application, Jardiance’s safety and effectiveness were evaluated in a randomized, double-blind, international trial comparing 5,998 patients. Fewer people were hospitalized due to cardiovascular failure and 3% fewer people died than in the placebo group. On the other hand, following the clinical trial, the FDA restricted Jardiance’s prescription to exclude people undergoing dialysis treatment.

The FDA noted that this approval would “provide physicians another tool to address heart disease” while adding that the significance of approving this drug coincides “with February’s annual observance of American Heart Month.” 

Heart failure is not a single disease; it is classified as a collection of related symptoms, also known as a syndrome. The syndrome of heart failure is defined as a condition in which the heart is not meeting the needs of the body. Heart failure becomes more common with age, especially for people over 65 years old, and while the individual presentation of heart failure symptoms may vary, common heart failure symptoms include shortness of breath, fatigue and swelling in the legs. 

According to the FDA, heart failure affects more than 650,000 people in the U.S. each year. Despite the prevalence of this condition and heart failure therapies covering multiple drug classes, mortality remains high and the FDA has stated that treatment options for a broader range of patients are needed.