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empafliglozin molecule

Regulatory agencies across the world have recommended empagliflozin (trade name Jardiance®) for the treatment of adults with chronic kidney disease (CKD). The recommendations are based on results from the EMPA-KIDNEY trial, the largest and broadest dedicated sodium-glucose co-transporter-2 (SGLT-2) inhibitor trial in CKD to date.

CKD affects 850 million people worldwide, including 47 million people in the EU, and over 35 million in the US. Disease progression can lead to the need for dialysis or transplantation, or cardiovascular death.

SGLT-2 inhibitors can help to lower blood glucose levels and were developed to treat diabetes. Empagliflozin is currently used for the treatment of heart failure and type 2 diabetes in adults. Use of the treatment for CKD could advance the standard of care for the millions of people living with CKD and other connected conditions.

To date, Jardiance has been recommended for use in adults with CKD at risk of disease progression in: Ecuador, Egypt, the European Union, Peru, Saudi Arabia, Taiwan, the United Arab Emirates, United Kingdom, and the US.

Professor William Herrington, Clinician Scientist at the Medical Research Council Population Health Research Unit at the University of Oxford, and EMPA-KIDNEY trial Co-Principal Investigator said ‘EMPA-KIDNEY demonstrated clearly that empagliflozin, a treatment developed for diabetes, reduces the risk of kidney disease progression or death from cardiovascular disease in people with chronic kidney disease.

‘Treatments such as empagliflozin had been shown to benefit certain types of CKD patients, but it was uncertain whether the treatment would work for patients without diabetes and others at risk of kidney disease progression who had been underrepresented in previous clinical trials. Thanks to the commitment of the trial participants and our collaborators around the world, we found that empagliflozin reduces the risk of kidney disease progression or death from cardiovascular disease significantly in patients with, and without, diabetes.’

‘These recommendations should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,’ added Co-Principal Investigator Professor Richard Haynes. ‘Slowing chronic kidney disease progression and avoiding the need for dialysis or a kidney transplant is highly desirable due to the adverse effects on quality of life, and the increased risk of cardiovascular disease.

‘EMPA-KIDNEY was a streamlined trial which minimised the burden on participants and the teams looking after them. These approvals show that such methods can provide the quality of data required by regulators, and change clinical practice for the benefit of public health.’

The EMPA-KIDNEY trial included 6,609 adults across the spectrum of CKD severity with a wide range of underlying causes and multiple conditions. Empagliflozin demonstrated a significant kidney and cardiovascular benefit in adults with CKD, reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent versus placebo.

Jardiance was recommended for approval in the EU by the Committee for Medicinal Products for Human Use of the European Medicines Agency in June 2023. Approval for use in the UK was granted by the Medicines and Healthcare products Regulatory Agency (part of the UK Government’s Department for Health and Social Care) in early September 2023, and guidance recommending empagliflozin as an option for the treatment of eligible adults with CKD was issued by the National Institute for Health and Care Excellence in December 2023. Approval for use in the US was granted by the US Food and Drug Administration (FDA) on 21 September 2023. The EMPA-KIDNEY trial was sponsored and co-funded by Boehringer Ingelheim, and co-funded by Lilly.

Responding to the FDA approval, Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim said ‘CKD is a global health crisis and often called a silent epidemic, resulting in a huge need for raising awareness and having additional treatment options. The FDA approval in CKD marks a crucial milestone in our mission to expedite access to empagliflozin for people living with interconnected cardio-renal-metabolic conditions.’

Read the EU press release.

Read the US press release.