FDA Accepts sNDA for Jardiance in Children 10 to 17 with Diabetes

The FDA has accepted a supplemental new drug application (sNDA) for Jardiance (empagliflozin) to lower blood sugar in children 10 years and older with type 2 diabetes. An FDA decision is expected in the second quarter of 2023. Developed by Boehringer Ingelheim and Eli Lilly, Jardiance is approved for several indications, including treating adults with type 2 diabetes, to reduce the risk of cardiovascular disease in adults with diabetes and to reduce the risk of heart failure.

The current list price for a month supply of Jardiance is $570.48, but patients can access a copay card for $10 per month.

“There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged 10-19 over the past two decades,” Mohamed Eid, M.D., vice president, clinical development & medical affairs, cardio-renal-metabolism & respiratory medicine at Boehringer Ingelheim Pharmaceuticals, said in a press release.

The sNDA is based on the results from the DINAMO phase 3 trial, which enrolled 158 patients between 10 and 17 years of age. They were randomized to Jardiance, Tradjenta (linagliptin) or placebo. The study found that Jardiance was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c at 26 weeks compared with placebo in participants aged 10 to 17 years with type 2 diabetes. Jardiance 10 mg and 25 mg pooled doses reduced A1c by 0.84% compared with placebo at week 26. Reduction in A1c in participants treated with Tradjenta was not statistically significant when compared with placebo. Results were presented during the International Diabetes Federation World Diabetes Congress 2022.

Overall, the safety data was consistent with the previously known safety profile of Jardiance.