Lilly, along with Boehringer, plans to seek regulatory approval for empagliflozin for the treatment of HFpEF, this year. Credit: Momoneymoproblemz.

Boehringer Ingelheim and Eli Lilly have reported that their oral drug empagliflozin met the primary goal in Phase III EMPEROR-Preserved trial in adults with heart failure with preserved ejection fraction (HFpEF).

Sold as Jardiance, empagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor administered once daily.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

It is the first type 2 diabetes drug to include data on cardiovascular death risk reduction in its label in various countries, Boehringer noted.

The EMPEROR-Preserved trial analysed the safety and efficacy of 10mg empagliflozin against placebo in 5,988 chronic HFpEF patients with or without diabetes.

Time to first adjudicated cardiovascular death or adjudicated hospitalisation for heart failure event was the trial’s primary goal.

Top-line data from the trial demonstrate empagliflozin as the first drug to substantially lower the risk of the composite of cardiovascular death or hospitalisation for heart failure in adult HFpEF patients.

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.

Furthermore, empagliflozin’s safety in the trial was in line with the already established profile.

The latest data add to earlier findings from the Phase III EMPEROR-Reduced trial.

In the EMPEROR-Reduced trial, empagliflozin mitigated the collective relative risk of cardiovascular death or hospitalisation for heart failure by 25% versus placebo in adults with heart failure with reduced ejection fraction (HFrEF).

Boehringer noted that these trials show the efficacy of the drug for people with all types of heart failure irrespective of ejection fraction.

Boehringer and Lilly intend to seek regulatory approval for empagliflozin in HFpEF indication this year.

Boehringer Ingelheim corporate vice-president and CardioMetabolic Medicine head Waheed Jamal said: “The totality of evidence from the trial points to the potential of empagliflozin to redefine treatment of heart failure with preserved ejection fraction, which affects approximately 30 million people worldwide.

“Until now, there have been no clinical studies demonstrating reduced risk of heart failure hospitalisations or cardiovascular mortality for all adults with this prevalent and life-limiting condition.”

Based on data from the EMPEROR-Reduced trial, the European Commission approved the use of Jardiance for the treatment of HFrEF in adults.