Source – Eli Lilly
On June 21, 2023, Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has authorized Jardiance (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years of age and older with type II diabetes.
Patients with type I diabetes are not advised to use Jardiance. In these individuals, it could raise the risk of diabetic ketoacidosis. In individuals with type II diabetes with an eGFR less than 30 mL/min/1.73 m2, Jardiance is not advised for usage to enhance glycemic control. Based on its mode of action, Jardiance is most likely useless in this situation.
“As the burden of type II diabetes increases among young people, so does the need for additional treatment options with proven clinical benefits. This FDA approval, which is based on the efficacy results and safety data from the DINAMO trial, marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population.”
– Lennart Jungersten, M.D., Ph.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim
In the United States, type II diabetes is a serious and expanding health risk for young people. Type II diabetes is now more common in people aged 10 to 19 than it was twenty years ago. To address the more than 5,700 new occurrences of type II diabetes that occur in this group each year in the US, additional therapeutic options are essential.
The DINAMO phase III study findings, which showed that Jardiance was linked with a statistically significant decrease in the primary endpoint of change from baseline in A1c at 26 weeks compared with placebo in individuals aged 10 to 17 years with type 2 diabetes, served as the foundation for the FDA’s approval. At week 26 (95% CI 1.5 to 0.2; P=0.0116), Jardiance 10 mg and 25 mg pooled dosages lowered A1c by 0.8% compared with placebo when added to additional baseline therapies (diet, exercise, metformin, and/or insulin). With the exception of the risk of hypoglycemia, which was greater in pediatric patients treated with Jardiance regardless of concurrent insulin administration, the safety profile of pediatric patients treated with Jardiance was comparable to that seen in adults with type II diabetes.
“With this latest FDA decision, Jardiance is now approved to lower A1c along with diet and exercise in children 10 years and older with type II diabetes,” said Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly. “This decision brings us one step closer in our efforts to improve outcomes for this population and supports our larger commitment to advance treatment options for people living with a range of cardiometabolic conditions.”
