FDA Expands Jardiance Approval for Heart Failure Patients | Health, Medicine and Fitness
MONDAY, Feb. 28, 2022 (HealthDay News) — Approval of Jardiance (empagliflozin) has been expanded to reduce the risk of cardiovascular death and hospitalization for heart failure in adults, the U.S. Food and Drug Administration announced Thursday. United.
Jardiance was previously approved in 2014 as a supplement to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The drug is also approved to reduce the risk of cardiovascular death in adults with both type 2 diabetes and cardiovascular disease and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. Jardiance is now approved for adults with heart failure with estimated glomerular filtration rate as low as 20ml/min/1.73m2.
The approval was based on data from EMPEROR-Preserved, a randomized, double-blind, international Phase III trial. Researchers randomly assigned 5,988 heart failure patients with left ventricular ejection fraction > 40% to 10 mg Jardiance as an add-on to standard treatment (2,997 patients) or placebo (2,991 patients) . Among people receiving Jardiance for an average of two years, 14% died of cardiovascular causes or were hospitalized for heart failure compared with 17% of patients who received placebo.
The most commonly reported adverse events with Jardiance include urinary tract infections and female fungal infections. The FDA notes that Jardiance should not be used in patients with a severe allergic reaction or in patients on dialysis.
“Although 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,” said Norman Stockbridge, MD, Ph.D., of FDA Center for Drug Evaluation and Research. , said in a press release from the agency.
Approval was granted to Boehringer Ingelheim.
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