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February 28, 2022updated 08 Mar 2022 9:17am

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

The approval is based on results from the Phase III EMPEROR-Preserved clinical trial of a once-daily dose of 10mg empagliflozin.

The US Food and Drug Administration (FDA) has granted approval to Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) 10mg to lower the risk of cardiovascular death and hospital admission in adult patients with heart failure.

According to the latest development, empagliflozin is indicated for use in adult heart failure patients with an eGFR as low as 20mL/min/1.73m2.5.

Empagliflozin is not intended for individuals with type 1 diabetes as it could surge diabetic ketoacidosis risk. 

Earlier, the FDA granted approval to Jardiance to lower the risk of cardiovascular death and hospitalisation for heart failure with reduced left ventricular ejection fraction (LVEF). 

The latest approval extends this indication to include all adult patients with heart failure. Adults with preserved LVEF are now included in the indication. 

The FDA decision is based on findings from the Phase III EMPEROR-Preserved clinical trial of a once-a-day dose of 10mg empagliflozin versus placebo, along with the standard of care therapy.

It enrolled 5,988 adult heart failure patients with LVEF over 40%. 

Data showed that Jardiance offered a 21% relative decline in risk of the composite primary endpoint of hospital admission for heart failure or cardiovascular death.

The benefit provided by empagliflozin was generally similar for LVEF subgroups in EMPEROR-Preserved and EMPEROR-Reduced trials.

Eli Lilly Product Development vice-president Jeff Emmick said: “This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure. 

“Building on the indication for heart failure with reduced ejection fraction last year, this decision marks the third US FDA approval for empagliflozin stemming from the EMPOWER programme and adds to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance spanning cardiovascular disease and type 2 diabetes.”

In August last year, Jardiance obtained FDA approval to reduce the cardiovascular death and hospitalisation risk in adult patients with heart failure with reduced ejection fraction (HFrEF).

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