Boehringer Ingelheim and Eli Lilly have secured approval from the European Commission (EC) for Jardiance (empagliflozin) to treat adults with chronic kidney disease (CKD).
Empagliflozin, an oral, once-daily, and highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, was also approved in the EU to treat type 2 diabetes (T2D) and heart failure.
It is claimed to be the first T2D drug to feature cardiovascular death risk reduction data for people with T2D and cardiovascular disease on its label in various countries.
Lilly diabetes and obesity global medical affairs senior vice-president Leonard Glass said: “We look forward to continuing conversations with other regulatory bodies worldwide so that empagliflozin can be made available for as many people living with these conditions as quickly as possible.”
The latest approval is based on data from EMPA-KIDNEY, which is a randomised, double-blind, multinational, and placebo-controlled clinical study.
This trial assessed the effect of empagliflozin on kidney disease progression and cardiovascular mortality risk in 6,609 participants.
Claimed to be the largest SGLT2 inhibitor trial in CKD so far, the study demonstrated a significant benefit of empagliflozin in lowering the relative risk of kidney disease progression or cardiovascular death by 28% compared with placebo in people suffering from CKD.
Furthermore, the trial showed a statistically significant relative risk reduction of hospitalisation for any cause by 14% compared with a placebo.
Boehringer Ingelheim human pharma head, Carinne Brouillon said: “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.”