The Latest Cardiac and Vascular News
– The breakthrough approval expands the existing indication of Jardiance® to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe – European marketing authorization follows the U.S. Food […]
– Adults hospitalized for acute heart failure were 36% more likely to experience a clinical benefit over 90 days if initiated on Jardiance after stabilization and before discharge compared with placebo – The benefit was consistent in adults with new […]
– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction – FDA approval marks a significant breakthrough for the approximately 3 million adults […]
SILVER SPRING, Md., Feb. 24, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as […]
– The positive opinion is based on the landmark EMPEROR-Preserved Phase III trial, which showed significant outcomes in patients with heart failure with left ventricular ejection fraction over 40%1 – If approved, Jardiance would be the first and only clinically proven treatment […]
If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum of heart failure regardless of ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 11, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has accepted a supplemental New […]
– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 9, […]
– In this clinical first for adults with heart failure with preserved ejection fraction, Jardiance demonstrated an impressive 21% relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure – The benefit in the […]
– The EMPEROR-Preserved phase III trial met its primary endpoint and demonstrated significant risk reduction with Jardiance for the composite of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction – Heart failure […]
– This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization for heart failure with reduced ejection fraction in adults with or without […]
