FDA approves Jardiance for the treatment of type 2 diabetes in children 10 years and older – Boehringer Ingelheim + Eli Lilly

The FDA has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company announced Jardiance is not recommended in patients with type 1 diabetes. It may increase the risk of diabetic ketoacidosis in these patients. Jardiance is not recommended for use to improve glycemic control in patients with type 2 diabetes with an eGFR less than 30 mL/min/1.73 m2. Jardiance is likely to be ineffective in this setting based upon its mechanism of action.

“As the burden of type 2 diabetes increases among young people, so does the need for additional treatment options with proven clinical benefits,” said Lennart Jungersten, M.D., Ph.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim. “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.”

Type 2 diabetes represents a significant and growing health concern among young people in the U.S. Over the past two decades, the prevalence of type 2 diabetes in people aged 10-19 has nearly doubled. New treatment options are critical to help address the over 5,700 new cases of type 2 diabetes in this population each year in the U.S.

The FDA approval is based on the results from the DINAMO phase III trial, in which 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 10-17 years with type 2 diabetes. When added to other baseline treatments (diet, exercise, metformin and/or insulin), Jardiance 10 mg and 25 mg pooled doses reduced A1c by 0.8% compared with placebo at week 26 (95% CI ?1.5 to ?0.2; P=0.0116). The safety profile of pediatric patients treated with Jardiance was similar to that observed in adults with type 2 diabetes, with the exception of hypoglycemia risk, which was higher in pediatric patients treated with Jardiance regardless of concomitant insulin use.