The application is based on phase 3 results from the DINAMO trial showing that Jardiance tablets significantly reduced A1C levels vs a placebo in participants aged 10 to 17 years.
The FDA has accepted a supplemental new drug application (sNDA) for empagliflozin (Jardiance) from Boehringer Ingelheim and Eli Lilly and Company as a potential new indication to lower blood sugar, in addition to diet and exercise, in children aged 10 to 17 years with type 2 diabetes (T2D).
“There are clear unmet needs for young [individuals] living with [T2D,] which has nearly doubled in prevalence in [those] aged 10-19 over the past 2 decades,” Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development & Medical Affairs in Cardio-Renal-Metabolism & Respiratory Medicine at Boehringer Ingelheim Pharmaceuticals Inc, said in a statement. “We look forward to working closely with the FDA during the review process and while we await a decision on our efforts to bring another potential treatment option to children 10 years and older with [T2D].”
The sNDA is based on results from the DINAMO phase 3 trial (NCT03429543), which showed empagliflozin was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c levels at 26 weeks compared with the placebo. Investigators included individuals aged 10 to 17 years old with T1D.
Additionally, investigators found that when added to other baseline treatments, including diet, exercise, insulin, and/or metformin, empagliflozin in the 10- and 25-mg dosages reduced A1c levels by 0.84% compared with the placebo at week 26.
The reduction in A1c levels in individuals treated with linagliptin (Tradjenta) from Boehringer Ingelheim was not statistically significant compared with the placebo.
Investigators also reported a numerical reduction of 0.34%.
The safety profile in this study was consistent with the previously known safety profile of empagliflozin.
Investigators enrolled individuals aged 10 to 17 years older with T2D who were previously treated with insulin or metformin. Of the 262 individuals screened, investigators assigned 158 to start empagliflozin 10 mg, linagliptin 5 mg, or the placebo, once daily.
Individuals in the empagliflozin group who did not have A1c levels below 7% by week 12 were re-randomized to either remain on 10 mg or increase to the 25-mg dosage.
At week 26, individuals who were in the placebo group were reassigned to empagliflozin 10 or 25 mg or linagliptin 5 mg.
The safety profile was assessed until week 52.
“If approved, [empagliflozin] would be a new oral treatment option for [T2D] in children 10 years and older in the United States, making this application acceptance an important step forward as we add to the body of knowledge for this vulnerable patient population, for whom oral treatment options have been limited,” Jeff Emmick, MD, PhD, vice president of Product Development at Lilly said in the statement.
Study results were presented during the International Diabetes Federation World Diabetes Congress 2022.
In 2014, empagliflozin was initially approved as a once-daily tabled with diet and exercise to lower blood sugar levels in individuals with T2D.
US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes. News release. Lilly. March 8, 2023. Accessed March 9, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-1