Eli Lilly and Company and Boehringer Ingelheim’s Jardiance (empagliflozin) has obtained priority review from the US Food and Drug Administration (FDA) to treat adults with heart failure regardless of left ventricular ejection fraction (LVEF).
The FDA accepted the supplemental New Drug Application and granted the priority review.
Jardiance is a prescription medicine, which is being assessed as a potential new treatment to lower the risk of cardiovascular death as well as hospitalisation in adults with heart failure independent of LVEF.
The sNDA submission was based on the data obtained from the global, double-blind, randomised, Phase III EMPEROR- Preserved clinical trial of Jardiance, which was performed on 5,988 patients with and without type 2 diabetes.
Data from this study showed that the drug was able to reduce the relative risk of cardiovascular death or hospitalisation for heart failure in adults with LVEF.
Eli Lilly and Company Product Development vice president Jeff Emmick said: “This milestone offers renewed hope to adults with heart failure with preserved ejection fraction, for whom treatment options are especially lacking.
“We believe Jardiance has the potential to be a transformative treatment in heart failure and look forward to working with the FDA during the review process toward a decision next year.”
In September this year, Jardiance received Breakthrough Therapy designation from the FDA to treat adults with heart failure with preserved ejection fraction (HFpEF).
It has also received Fast Track designation for reducing the cardiovascular death risk and hospitalisation for heart failure.
Boehringer Ingelheim Cardio-Metabolism & Respiratory Medicine Clinical Development & Medical Affairs vice president Mohamed Eid said: “If approved, Jardiance would be the first and only therapy clinically proven to significantly improve outcomes in a heart failure population that included a majority of people with preserved ejection fraction.”