EMPA-KIDNEY is a randomised, double-blind, placebo-controlled clinical trial that studied the effect of Jardiance (empagliflozin) on progression of kidney disease and cardiovascular death risk in CKD patients
Boehringer Ingelheim and Lilly reported positive results for Jardiance in the EMPA-KIDNEY trial. (Credit: PR Newswire/Boehringer Ingelheim International GmbH/Eli Lilly and Company)
Boehringer Ingelheim and Eli Lilly and Company (Lilly) have announced that their diabetes drug Jardiance (empagliflozin) has met the primary endpoint of the EMPA-KIDNEY phase 3 clinical trial by showing a significant kidney and cardiovascular benefit for adult patients with chronic kidney disease (CKD).
EMPA-KIDNEY trial is a randomised, double-blind, placebo-controlled clinical trial that studied the effect of empagliflozin on progression of kidney disease and cardiovascular death risk.
Claimed to be the largest SGLT2 inhibitor CKD trial, the study enrolled 6,609 participants with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. The participants with established CKD both with and without diabetes were given either empagliflozin 10mg or a placebo, in addition to current standard of care.
Jardiance was found to have reduced the risk of kidney disease progression or cardiovascular death in the late-stage trial significantly by 28% compared to placebo.
The drug also met one of the key secondary confirmatory endpoints of the EMPA-KIDNEY trial by showing a significant reduction of 14% in all-cause hospitalisations, when compared to placebo.
Boehringer Ingelheim human pharma head Carinne Brouillon said: “The Boehringer Ingelheim and Lilly Alliance is incredibly proud that EMPA-KIDNEY has provided another pivotal moment for Jardiance.
“Today’s data adds to the body of evidence from our clinical program which includes more than 700,000 adults with cardiovascular, kidney and metabolic conditions.
“EMPA-KIDNEY reinforces the potential role of empagliflozin in changing the way these interconnected conditions may be managed.”
Boehringer Ingelheim and its partner Lilly aim to secure an extended authorisation for CKD with regulators globally.
In September this year, Boehringer Ingelheim received approval from the US Food and Drug Administration (FDA) for Spevigo for the treatment of generalised pustular psoriasis (GPP) flares in adults.