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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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. 

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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).