The approval for this new indication is based on results from the Study of Heart and Kidney Protection With Empagliflozin (EMPA-KIDNEY) trial, report Boehringer Ingelheim and Lilly in a statement. The companies will jointly market the drug,
Empagliflozin is the first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalizations for people with CKD in comparison with placebo.
"CKD doubles a person's risk for hospitalization and is a leading cause of death globally. In the European Union (EU), hospitalizations account for up to 70% of total healthcare costs for people with CKD," according to the statement.
As reported earlier, empagliflozin first received US Food and Drug Administration (FDA) marketing approval for improving glycemic control in patients with type 2 diabetes in 2014. In 2016, it was additionally approved for reducing cardiovascular death for patients with type 2 diabetes and cardiovascular disease, and in 2019, it was approved for treating adults with heart failure with reduced ejection fraction.
The new indication for CKD will allow an integrated approach to the treatment of patients with interconnected conditions.
"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 optimized treatment of these interconnected conditions," says Leonard Glass, MD, senior vice president, Diabetes and Obesity Global Medical Affairs, Lilly.
"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," he adds.
In January 2023, the FDA accepted a supplemental new drug application for empagliflozin as a potential treatment for reducing the risk of kidney disease progression and cardiovascular death among adults with CKD. A decision is expected in the second half of 2023.
Approval Arises From EMPA-KIDNEY Results
The EC's approval of this new indication for empagliflozin is based on results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date.
The trial randomly assigned 6609 adults with established CKD to receive empagliflozin 10 mg/day or placebo in addition standard care. The trial included some patients with and some without diabetes, as well as some patients with and some without albuminuria.
During a median follow-up of 2.0 years, the relative risk of the primary combined endpoint — kidney disease progression or cardiovascular death — was reduced by 28% with empagliflozin in comparison with placebo (hazard ratio [HR], 0.72; P < .000001).
The relative risk of hospitalization for any cause was reduced 14% with empagliflozin in comparison with placebo (HR, 0.86; P = .0025).
The overall safety data were generally consistent with previous findings.
Canagliflozin, Dapagliflozin Also Approved for Kidney Disease
As reported earlier, two other SGLT2 inhibitors are already approved by the FDA for treating kidney disease.
Canagliflozin (Invokana, Janssen Pharmaceuticals) was approved for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019. That approval was based on results from the CREDENCE trial.
Lead image: Lilly and Boehringer Ingelheim
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Cite this: Europe Approves Empagliflozin for Chronic Kidney Disease - Medscape - Jul 27, 2023.