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 FDA's Center for Drug Evaluation and Research. "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."
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. Symptoms of heart failure vary but can include shortness of breath, fatigue and swelling in the legs. Heart failure becomes more common with age and is the leading cause of hospitalization in people over 65 years old.
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.
See the prescribing information for additional information on risks associated with Jardiance.
Jardiance received Priority Review designation for this indication.
The FDA granted the approval of Jardiance to Boehringer Ingelheim.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.