UK MHRA Grants Approval of Jardiance

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 announced.

This approval has the potential to advance the standard of care for more than 7.2 million people in the UK living with CKD, and may help relieve the burden on healthcare systems by reducing the risk of all-cause hospitalisation for people with the disease. 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.

“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 as well as reducing the risk of cardiovascular disease. CKD accounts for 40-45,000 premature deaths every year in the UK. 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.

“CKD progression can ultimately lead to a need for dialysis or kidney transplantation, and new treatments proven to delay this progression are incredibly welcome” added William Herrington, Honorary Consultant Nephrologist, Oxford Kidney Unit, Associate Professor at the Medical Research Council Population Health Research Unit at the University of Oxford and EMPA-KIDNEY clinical trial co-Principal Investigator. “Treatment with empagliflozin can also reduce the likelihood of hospitalisation, thereby having the potential to positively impact the healthcare burden associated with this common condition.”

The MHRA approval is based on results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date, which showed a significant benefit of empagliflozin in reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent vs. placebo in people with CKD (HR 0.72; 95% CI 0.64 to 0.82; P<0.000001 [absolute risk reduction 3.8%]). The trial also demonstrated a statistically significant relative risk reduction in hospitalisation for any cause by 14 percent vs. placebo (HR 0.86; 95% CI 0.78 to 0.95; p=0.0025 [absolute risk reduction 4.4%]). The overall safety data were generally consistent with previous findings, confirming the well-established safety profile of empagliflozin.