Empagliflozin approved in the EU for CKD

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The European Commission (EC) has approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company has announced. The approval, states a press release, “has the potential to advance the standard of care” for more than 47 million people in the EU living with CKD, and to “help relieve burden on healthcare systems by reducing the risk of all-cause hospitalisation” for people with CKD. 

With existing indications in type 2 diabetes and heart failure, the release says, empagliflozin “could help manage the risks of cardio-renal-metabolic conditions, which are often interconnected”. Cardio-renal-metabolic conditions affect over 1 billion people worldwide.

“We celebrate this significant milestone in the field of chronic kidney disease. CKD is a silent killer and prevention and early detection are crucial in the general population,” said Daniel Gallego, president of the European Kidney Patients Federation. “This new treatment option has the potential to further improve the management of cardiorenal metabolic syndrome and renal disease, offering renewed hope and improved quality of life for countless individuals living with CKD worldwide.”

The approval is based on results from the EMPA-KIDNEY trial, the “largest and broadest dedicated SGLT2 inhibitor (SGLT2i) 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% vs. placebo in people with CKD (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.64–0.82; 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% vs. placebo (HR 0.86; 95% CI 0.78 to 0.95; p=0.0025 [absolute risk reduction 4.4%]). The overall safety data was generally consistent with previous findings, “confirming the well-established safety profile of empagliflozin”. CKD doubles a person’s risk for hospitalization and is a leading cause of death globally, the press release goes on to say, adding that hospitalisations account for up to 70% of total healthcare costs for people with CKD in the EU.

“Living with CKD can have a drastic impact on patients and their family’s lives. CKD not only affects individuals but also society overall due to the high economic burden to healthcare systems,” said Carinne Brouillon, head of human pharma at Boehringer Ingelheim. “As we deepen our knowledge in interconnected cardio-renal-metabolic conditions, we are very excited about the approval and the potential for empagliflozin to play an essential role in helping patients, their physicians and healthcare systems.”

“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 empagliflozin can be made available for as many people living with these conditions as quickly as possible,” added Leonard Glass, senior vice president of Diabetes & Obesity Global Medical Affairs at Lilly (Indianapolis, USA).

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