Blog

Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) has been approved by the European Commission (EC) as a treatment option for adults with chronic kidney disease (CKD).

Approximately 47 million people in the EU are affected by CKD, a long-term condition characterised by a gradual loss of kidney function.

With CKD mostly being asymptomatic until the later stages of the condition, most patients go undiagnosed and every year millions die prematurely from CKD and its related complications, which include hypertension, diabetes, obesity, primary renal disorders and anaemia.

Jardiance, which is already approved in the EU to treat adults with type 2 diabetes and heart failure, is a once-daily, oral inhibitor of the sodium glucose co-transporter-2 that works by increasing sugar lost in the urine.

The EC’s latest decision on the drug is supported by positive results from the late-stage EMPA-KIDNEY trial, which evaluated the effect of Jardiance on kidney disease progression and cardiovascular mortality risk in 6,609 patients across a wide range of underlying causes.

The study met its primary endpoint, showing that Jardiance reduced the risk of kidney disease progression or cardiovascular death by 28% versus placebo.

A 14% reduction in all-cause hospitalisations versus placebo was also demonstrated, meeting one of the pre-specified key secondary confirmatory endpoints of the study.

Daniel Gallego, president of the European Kidney Patients’ Federation, described the approval as a “significant milestone in the field of CKD”.

He continued: “This new treatment option has the potential to further improve the management of cardio-renal-metabolic syndrome and renal disease, offering renewed hope and improved quality of life for countless individuals living with CKD worldwide.”

Leonard Glass, senior vice president, diabetes and obesity global medical affairs, Lilly, said: “CKD is closely linked to other cardio-renal-metabolic conditions such as type 2 diabetes and heart failure – thus an integrated approach is vital for optimised treatment of these interconnected conditions.

“We look forward to continuing conversations with other regulatory bodies worldwide so that [Jardiance] can be made available for as many people living with these conditions as quickly as possible.”

The approval comes just over a week after Lilly said it would be acquiring Versanis for over $1.9bn in a bid to expand its cardio-metabolic disease pipeline.

The deal gives Lilly access to Versanis’ lead asset, bimagrumab, a monoclonal antibody currently being assessed in a mid-stage trial as both a monotherapy and in combination with Novo Nordisk’s semaglutide in adults who are overweight or obese.