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

Written by | 27 Jun 2023 | Diabetes & Endocrinology

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.

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