The supplemental new drug application is based on results from a landmark phase 3 trial showing that empagliflozin tablets provided meaningful results.
The FDA has accepted a supplemental new drug application (sNDA) for empagliflozin tablets (Jardiance) from Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company, which is being investigated as a potential treatment to reduce the risk of disease progression and cardiovascular death in individuals with chronic kidney disease (CKD).
“There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs in cardio-renal-metabolism and respiratory medicine at Boehringer Ingelheim, said in a statement. “This application acceptance is an important step forward for the approximately 37 million [individuals] in the [United States] living with CKD.”
The sNDA is based on results from EMPA-KIDNEY (NCT03594110), a phase 3 trial, which showed that empagliflozin significantly reduced the risk of disease progression or cardiovascular death in individuals with CKD by 28% compared with the placebo. Both arms were used, in addition to the standard of care.
The study was the first (sodium-glucose co-transporter 2) SGLT2 inhibitor CKD trial to show a significant reduction in the risk of hospitalization of any cause, at a 14% relative risk reduction with empagliflozin compared with the placebo and the top of standard of care.
Investigators also saw that the reductions in key secondary endpoints, including hospitalization for heart failure, cardiovascular death, or all-cause death were not statistically significant.
“This marks another exciting milestone for [empagliflozin], potentially extending its ability to positively impact the approximately 1 billion [individuals] diagnosed with a cardio, renal, or metabolic condition,” Jeff Emmick, MD, PhD, vice president of product development at Lilly, said in the statement. “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.”
EMPA-KIDNEY was the largest and broadest SGLT2 inhibitor trial for CKD to date and provided additional data for individuals who are commonly seen in clinical practice. Investigators enrolled 6609 individuals, including individuals without diabetes, those with underlying causes of CKD, and those across the spectrum of estimated glomerular filtration rate (eGFR) and urine albumin-creatine ratio.
The safety profile from the trial was consistent with the previously known safety profile for empagliflozin.
Empagliflozin is a once-daily tablet that is prescribed alongside diet and exercise to lower blood sugar for individuals with type 2 diabetes (T2D). It also is indicated to reduce the risk of cardiovascular death with T2D and known cardiovascular diseases.
Empagliflozin can also be used to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in individuals with HF.
It is not used for individuals with type 1 diabetes or to improve glycemic control in individuals with T2D with an eGFR <30 mL/min/1.73 m2.
The results were presented during the American Society of Nephrology’s Kidney Week 2022 and published in The New England Journal of Medicine.
US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease. Lilly. News release. January 20, 2023. Accessed January 23, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-0