FDA to Review Application for Empagliflozin for Adults with Chronic Kidney Disease

The FDA has accepted a supplemental New Drug Application for empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) for the treatment of adults with chronic kidney disease (CKD). Empagliflozin is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Notably, it is the first type 2 diabetes medication to include cardiovascular death risk reduction data in its label in several countries, according to a press release. It is currently being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD, as well.

“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” said Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development and Medical Affairs for Cardio-Renal-Metabolism and Respiratory Medicine at Boehringer Ingelheim Pharmaceuticals, in the press release. “This application acceptance is an important step forward for the approximately 37 million people in the [United States] living with CKD.”

The application is based on results from the landmark EMPA-KIDNEY phase 3 trial, in which empagliflozin significantly reduced the risk of kidney disease progression or cardiovascular death in adults with CKD by 28% compared with placebo, both of which were administered in addition to standard of care. Results were presented during the American Society of Nephrology Kidney Week 2022 and published in The New England Journal of Medicine.

EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to demonstrate a significant reduction in the risk of hospitalization for any cause, with a 14% relative risk reduction with empagliflozin versus placebo in a pre-specified key secondary endpoint. Particularly, the study found 24.8 events per 100 patient-years in the empagliflozin arm compared with 29.2 events per 100 patient-years in the placebo arm.

The trial enrolled 6609 participants, including individuals without diabetes (56%), those with various underlying causes of CKD, and those across the spectrum of estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio. Overall, the safety data in EMPA-KIDNEY were consistent with the previously known safety profile of empagliflozin.

Reductions in other key secondary endpoints of hospitalization for heart failure, cardiovascular death, or all-cause death were not statistically significant in the EMPA-KIDNEY trial. Hospitalizations account for 35% to 55% of total health care costs for individuals with CKD in the United States, according to the press release.

“This marks another exciting milestone for Jardiance, potentially extending its ability to positively impact the approximately 1 billion people diagnosed with a cardio, renal, or metabolic condition,” said Jeff Emmick, MD, PhD, vice president of product development at Lilly, in the press release. “We look forward to working with the FDA during the review process and eagerly await a decision later this year on the indication for CKD, which doubles a person’s risk for hospitalization.”

Empagliflozin is currently indicated to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. It is also indicated to reduce the risk of cardiovascular death and heart failure in adults with heart failure.

REFERENCE

US FDA accepts supplemental New Drug Application for Jardiance for adults with chronic kidney disease. News release. Boehringer Ingelheim; January 24, 2023. Accessed January 25, 2023. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/fda-accepts-new-chronic-kidney-disease-treatment-application