The drug 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. It is also approved to reduce the risk of cardiovascular death in adults with Type 2 diabetes and established cardiovascular disease.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” stated Norman Stockbridge, MD, PhD, 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,” he added. “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.”
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