FDA approves Jardiance for heart failure in adults

The food and drug administration has granted the approval of Jardiance to Boehringer Ingelheim.

Heart failure is a syndrome in which the heart is not meeting the needs of the body, affecting more than 650,000 people in the U.S. each year. Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed.

Jardiance was 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 is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction

"Today's approval will provide a treatment option for a wider range of patients with heart failure," said Norman Stockbridge, M.D., Ph.D., Director of the Division of Cardiology and Nephrology in the Center for Drug Evaluation and Research of food and drug administration. "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. Coinciding with February's annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease."

For today's approval, Jardiance's safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo. The main efficacy measurement was the time to death from cardiovascular causes or need to be hospitalized for heart failure. Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo. This benefit was mostly attributable to fewer patients being hospitalized for heart failure.

The side effects in clinical studies with Jardiance for patients with heart failure were generally consistent with side effects for patients with diabetes. In diabetic patients, the most common adverse events were urinary tract infections and female fungal infections. Jardiance must not be used in patients who previously have had a serious allergic reaction to it as well as patients on dialysis.

Jardiance had earlier received Priority Review designation for  use in heart failure by the food and drug administration.