Tag: Jardiance

US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction

RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart […]

Jardiance® reduced the risk of first plus recurrent cardiovascular events in adults with type 2 diabetes and established cardiovascular disease in new analysis from the EMPA-REG OUTCOME® trial

– In new results published in The Lancet Diabetes & Endocrinology, Jardiance reduced the risk of total (first plus recurrent) cardiovascular events including 3P-MACE, hospitalization for heart failure and all-cause hospitalization versus placebo in adults with type 2 diabetes and […]

New Jardiance® findings showed improved cardio-renal outcomes in adults with heart failure with reduced ejection fraction regardless of chronic kidney disease status

– Jardiance (empagliflozin) reduced risk for the composite endpoint of cardiovascular death and hospitalization for heart failure, as well as serious adverse kidney outcomes, in adults with or without chronic kidney disease at baseline. The trial included people with and […]

US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack

– FDA Fast Track designation facilitates the development of potential new therapies that treat serious conditions and fulfill an unmet medical need – This Fast Track designation for empagliflozin emphasizes the urgent need for potential treatments that may improve outcomes […]

Jardiance® meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes

– Jardiance (empagliflozin) significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction – Treatment of heart failure is […]