The EC’s approval is based on results from the EMPA-KIDNEY trial in which Jardiance reduced the relative risk of kidney disease progression or cardiovascular death by 28% versus placebo in people with CKD
Eli Lilly, Boehringer’s Jardiance gets clearance in EU. (Credit: HeungSoon from Pixabay)
Boehringer Ingelheim and Eli Lilly have announced that the European Commission (EC) approved Jardiance (empagliflozin) to treat adult patients with chronic kidney disease (CKD) in the European Union (EU).
Jardiance is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor.
It is said to be the first type 2 diabetes medicine to include cardiovascular death risk reduction data for people with type 2 diabetes and cardiovascular disease on its label in several nations.
The EC’s approval is based on results from the EMPA-KIDNEY trial.
In the trial, Jardiance reduced the relative risk of kidney disease progression or cardiovascular death by 28% versus placebo in people with CKD.
The study also demonstrated a statistically significant relative risk reduction in hospitalisation for any cause by 14% compared to placebo.
According to Boehringer Ingelheim, the overall safety data was generally consistent with previous findings, validating the safety profile of empagliflozin.
Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “Living with chronic kidney disease can have a drastic impact on patients and their family’s lives. CKD not only affects individuals, but also society overall due to the high economic burden on healthcare systems.
“As we deepen our knowledge in interconnected cardio-renal-metabolic conditions, we are very excited about the approval and the potential for empagliflozin to play an essential role in helping patients, their physicians and healthcare systems.”
EMPA-KIDNEY is a randomised, double-blind, placebo-controlled clinical trial to assess the effect of empagliflozin on kidney disease progression and cardiovascular death risk.
It recruited 6,609 participants from eight countries across a wide range of underlying causes.
The trial defined the primary outcome as a time to a first event of either cardiovascular death or kidney disease progression, a sustained decline in eGFR to <10 mL/min/1.73 m2, kidney death, or a sustained decline of ≥40% in eGFR from randomisation.
Key secondary outcomes consisted of cardiovascular death or hospitalisation for heart failure, all-cause hospitalisation, and all-cause mortality.
Last month, Eli Lilly and Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) authorised Jardiance to treat type 2 diabetes in children.