UK MHRA grants approval of Jardiance® (empagliflozin) for the treatment of adults with chronic kidney disease
- Chronic kidney disease (CKD) affects 7.2 million people in the UK, more than 1 in 10 of the population,[i] and accounts for 40-45,000 premature deaths every year[ii]
- Jardiance® (empagliflozin) is the first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in people with CKD vs. placebo,[iii]
- The approval in CKD adds to existing indications in type 2 diabetes and heart failure[iv]
Bracknell, UK. 7 September 2023 – The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jardiance® (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. This approval has the potential to advance the standard of care for more than 7.2 million people in the UK living with CKD,1 and may help relieve the burden on healthcare systems by reducing the risk of all-cause hospitalisation for people with the disease.3 With existing indications in type 2 diabetes and symptomatic chronic heart failure, empagliflozin could help manage the risks of cardio-renal-metabolic conditions, which are often interconnected. A US study has shown that as many as 94% of people with type 2 diabetes live with at least one cardiovascular or renal comorbidity.[v]
“The MHRA approval of empagliflozin is positive news for people living with chronic kidney disease and for healthcare professional who have had limited treatment options for their patients” said Dr Kevin Fernando, GPwSI CVRM and Medical Education. “With new and effective treatments available, it is now even more important in primary care that we identify and manage CKD at an early stage to slow the disease and avoid future complications that can substantially impact on people’s quality of life and longevity.”
Early identification, diagnosis, and treatment of people with CKD is critical to preserving and protecting kidney function[vi] as well as reducing the risk of cardiovascular disease.[vii] CKD accounts for 40-45,000 premature deaths every year in the UK.2 The total annual economic burden of kidney disease in the UK is £7 billion, with £6.4 billion being direct costs to the NHS, which equates to approximately 3.2% of NHS budgets.1
“We are committed to improving the care and outcomes for people affected by cardio-renal-metabolic diseases which touch the lives of so many across the UK. The approval for empagliflozin by the MHRA now means clinicians can offer the benefits of empagliflozin to people with chronic kidney disease in addition to its use for treating symptomatic chronic heart failure and type 2 diabetes,” said Dr Christoph Zehendner, Medical Director, Boehringer Ingelheim UK & Ireland.
[i]Kidney Research UK, Kidney disease: A UK public health emergency. The health economics of kidney disease to 2033. June 2023. Available at: https://www.kidneyresearchuk.org/wp-content/uploads/2023/06/Economics-of-Kidney-Disease-full-report_accessible.pdf Accessed: September 2023
[ii] Kidney Care UK, Facts about Kidneys. Available at: https://www.kidneycareuk.org/news-and-campaigns/facts-and-stats/ Accessed: September 2023
[iii] The EMPA-KIDNEY Collaborative Group. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023; 388:117-127.
[iv] Jardiance® (empagliflozin) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/5441/smpc. Accessed: September 2023.
[v] Giorgino F et al. Cardiovasc Diabetol 2020 Nov 22;19(1):196. doi: 10.1186/s12933-020-01163-9.
[vi] Chen TK, et al. JAMA. 2019;1;322(13):1294-1304.
[vii] National Institute for Health and Care Excellence. CVD prevention: chronic kidney disease detection and management. Available at: https://stpsupport.nice.org.uk/cvd-prevention-ckd/index.html#:~:text=The%20aim%20of%20early%20identification,dialysis%20or%20a%20kidney%20transplant Accessed September 2023
