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FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.
FDA approved Jardiance (empagliflozin) on Feb. 24, 2022 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
According to FDA, heart failure affects more than 650,000 people in the United States each year and is the leading cause of hospitalization in people over 65 years of age. Symptoms commonly include shortness of breath, fatigue, and swelling in the legs.
Empagliflozin is meant to reduce the risk of cardiovascular death and hospitalization for patients with heart failure. The drug was originally approved by FDA in 2014 as a diet and exercise supplement to improve glucose control in adults with type 2 diabetes. Empagliflozin 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,” said Norman Stockbridge, M.D., PhD, director of the Division of Cardiology and Nephrology in FDA’s Center for Drug Evaluation and Research, in a press release. “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.”