Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

The submission of sNDA is based on the data obtained from the Phase III EMPA-KIDNEY trial, which assessed the effect of Jardiance for the same indication.

Findings from the trial showed that the drug significantly reduced kidney disease progression and cardiovascular mortality risk by 28% in CKD adult patients compared to the placebo.

Lilly Product Development vice-president Jeff Emmick said: “This marks another exciting milestone for Jardiance, potentially extending its ability to positively impact the approximately one billion people diagnosed with a cardio, renal or metabolic condition.

“We look forward to working with the FDA during the review process and eagerly await a decision later this year on the indication for CKD, which doubles a person’s risk for hospitalisation.”

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.

The company stated that the drug received Fast Track designation from the US FDA for the same indication in March 2020.

Jardiance was initially approved in 2014 as a once-a-day tablet for use with diet and exercise to reduce blood sugar in type 2 diabetes adult patients.

It has also been approved for reducing cardiovascular death risk in type 2 diabetes and known cardiovascular disease adult patients.

Additionally, the therapy has received approval for reducing cardiovascular mortality and hospitalisation risk in adult heart failure patients.