FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure
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FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure

12 Nov 2021 (Last Updated November 12th, 2021 12:01)

The FDA accepted an sNDA, which is based on data from the Phase III trial of the therapy.

FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure
Jardiance is approved to lower the risk of cardiovascular death and hospitalisation in HFrEF patients. Credit: Steve Buissinne / Pixabay.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly have obtained the US Food and Drug Administration (FDA) priority review for Jardiance (empagliflozin) to potentially treat heart failure not associated with left ventricular ejection fraction (LVEF).

The FDA accepted a supplemental New Drug Application (sNDA) of the companies and granted priority review for Jardiance that is being assessed as a potential therapy to lower cardiovascular death and hospitalisation risk in heart failure patients.

The sNDA submitted to the FDA is based on data from the global, double-blind, randomised Phase III EMPEROR-Preserved clinical trial, which enrolled 5,988 adult subjects respective of their type 2 diabetes status.

Subjects were categorised to receive either a once-daily dose of 10mg Jardiance or placebo, along with guideline-directed treatment for heart failure.

The trial’s composite primary goal was the time to the first occurrence of cardiovascular death or hospitalisation due to heart failure.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly have obtained the US Food and Drug Administration (FDA) priority review for Jardiance (empagliflozin) to potentially treat heart failure not associated with left ventricular ejection fraction (LVEF).

The FDA accepted a supplemental New Drug Application (sNDA) of the companies and granted priority review for Jardiance that is being assessed as a potential therapy to lower cardiovascular death and hospitalisation risk in heart failure patients.

The sNDA submitted to the FDA is based on data from the global, double-blind, randomised Phase III EMPEROR-Preserved clinical trial, which enrolled 5,988 adult subjects respective of their type 2 diabetes status.

Subjects were categorised to receive either a once-daily dose of 10mg Jardiance or placebo, along with guideline-directed treatment for heart failure.

Findings showed that Jardiance showed a relative decline of 21% in risk for the composite primary endpoint in trial subjects over placebo.

Boehringer Ingelheim Pharmaceuticals Cardio-Metabolism and Respiratory Medicine Clinical Development and 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.

“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.”

In August, the FDA granted approval for Jardiance to reduce cardiovascular death and hospitalisation risk in adult patients suffering from heart failure with reduced ejection fraction.