The approval was based on the data from the EMPA-KIDNEY trial in which Jardiance showed a 28% relative risk reduction compared with placebo, both on top of standard care
Boehringer Ingelheim site in Germany. (Credit: Boehringer Ingelheim)
Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10mg tablets to treat adult patients with chronic kidney disease (CKD).
Jardiance is an oral, once-daily, highly selective prescription-based sodium-glucose cotransporter 2 (SGLT2) inhibitor.
The FDA has approved Jardiance to lower the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalisation in CKD patients who are at risk of progression.
The approval was based on the data from the EMPA-KIDNEY trial that was designed to reflect the broad range of CKD adults with or without type 2 diabetes.
In the trial, Jardiance showed a 28% relative risk reduction compared with placebo, both on top of standard care, for the composite primary endpoint of kidney disease progression or cardiovascular death.
EMPA-KIDNEY is said to be the first SGLT2 inhibitor CKD trial to show a significant reduction in the risk of first and recurrent hospitalisation, a pre-specified key secondary endpoint, with a 14% relative risk reduction with Jardiance against placebo.
Boehringer Cardio-Renal-Metabolism & Respiratory Medicine Clinical Development & Medical Affairs VP Mohamed Eid said: “Given the clinically demonstrated benefits of Jardiance, we are proud to now be able to offer this option to adults with CKD at risk for progression.”
EMPA-KIDNEY, which also backed Jardiance’s approval in the European Union in July, is a multinational, randomised, double-blind, placebo-controlled trial with a goal to assess the effect of SGLT2 inhibitor on kidney disease progression and cardiovascular death risk.
It enrolled 6,609 adults from eight countries who were randomised to get either Jardiance 10mg or placebo, once daily, both after the existing standard of care.
The primary endpoint is defined as the time to the first event of either cardiovascular death or kidney disease progression.
Key secondary outcomes consist of cardiovascular death or hospitalisation for heart failure, all-cause hospitalisation and all-cause mortality.