Boehringer Ingelheim and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance? (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction (LVEF). The sNDA is based on results from the EMPEROR-Preserved? phase III trial, in which Jardiance was associated with a 21% relative risk reduction (3.3% absolute risk reduction) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF over 40% compared with placebo. Results were independent of ejection fraction or diabetes status. Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine. According to the FDA, a Priority Review designation is intended to direct overall attention and resources to the evaluation of applications for a treatment that, if approved, would be a significant improvement in the safety or effectiveness of treatments for serious conditions. In September, the FDA also granted Breakthrough Therapy designation to Jardiance as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF). Jardiance is currently indicated to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction. Jardiance is not for type 1 diabetes, or to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73m2. Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, and in patients on dialysis. HFpEF accounts for approximately half of the more than 6 million heart failure cases in the U.S. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF. The FDA previously granted Fast Track designation for the development of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure. The Fast Track designation is for the EMPEROR program, which consists of the EMPEROR-Reduced? and EMPEROR-Preserved trials. The EMPEROR-Reduced results formed the basis of the recent FDA approval for heart failure with reduced ejection fraction. Jardiance is not indicated for the treatment of HFpEF.