FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance
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 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.”
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 together 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 heart failure adult patients.
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