Boehringer and Lilly’s Jardiance granted MHRA approval to treat chronic kidney disease
07 Sep 2023
Clinical ResultDrug ApprovalPhase 3AHA
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Source: PMLiVE
Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment option for adults with chronic kidney disease (CKD).
Approximately 7.2 million people in the UK 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, up to 45,000 people in the UK die prematurely from CKD and its related complications, including hypertension, diabetes, obesity, primary renal disorders and anaemia.
Jardiance, which is already approved in the UK to treat 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 MHRA's latest decision is supported by positive results from the late-stage EMPA-KIDNEY trial, which evaluated the effects 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.
“CKD progression can ultimately lead to a need for dialysis or kidney transplantation, and new treatments proven to delay this progression are incredibly welcome,” said EMPA-KIDNEY co-principal investigator, William Herrington.
Herrington continued: “Treatment with [Jardiance] can also reduce the likelihood of hospitalisation, thereby having the potential to positively impact the healthcare burden associated with this common condition.”
The approval comes less than two months 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.
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