FDA Accepts Supplemental NDA for Jardiance

Boehringer Ingelheim and Eli Lilly have submitted a supplemental NDA for Jardiance (empagliflozin) as a treatment to reduce the risk of cardiovascular death for heart failure in adults with left ventricular ejection fraction (LVEF).

The submission is based on the results from the EMPEROR-Preserved phase 3 trial, in which Jardiance was associated with a 21% relative risk reduction (3.3% absolute risk reduction) for the composite primary end point 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.

Related: Study Shows Jardiance Improves Heart Failure Outcomes

Mohamed Eid, M.D.

“Building on the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this supplemental new drug application acceptance is a step toward the potential to make Jardiance the sole treatment to demonstrate a statistically significant benefit for adults across the full spectrum of heart failure regardless of ejection fraction,” Mohamed Eid, M.D., vice president, clinical development and medical affairs, Cardio-Metabolism & Respiratory Medicine at Boehringer Ingelheim, said in a statement.

The FDA has granted the application priority review. In September 2021, the FDA also granted breakthrough designation to Jardiance treatment for adults with heart failure with preserved ejection fraction (HFpEF). HFpEF accounts for about half of the more than 6 million heart failure cases in the United States. No currently approved treatments have been shown to improve outcomes for people with HFpEF.

Jardiance is currently approved to reduce the risk of cardiovascular death for heart failure in adults with heart failure and reduced ejection fraction.