The US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets for lowering blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company have announced.
“As the burden of type 2 diabetes among young people increases, so does the need for additional treatment options with proven clinical benefits,” said Lennart Jungersten, senior vice president, medicine & regulatory affairs, Boehringer Ingelheim.
“This FDA approval, which is based on efficacy results and safety data from the DINAMO trial, marks an important milestone in helping address the clearly unmet need for oral treatment options, other than metformin, to lower A1c in this rapidly increasing population. ”
Type 2 diabetes is a significant and growing health problem among young people in the US. 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 helping address the more than 5,700 new cases of type 2 diabetes in this population each year in the US.
Trial results for Jardiance
FDA approval was based on the results of the DINAMO phase III trial, in which Jardiance was associated with a statistically significant reduction in the primary end point of change from baseline at A1c at 26 weeks compared to placebo in participants aged 10–17 years with type 2 diabetes. When added to other initial treatments (diet, exercise, metformin and/or insulin), the combined dose of Jardiance 10 mg and 25 mg 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 the risk of hypoglycemia, which was higher in pediatric patients treated with Jardiance regardless of concomitant insulin use.
Jardiance is contraindicated in persons with hypersensitivity to empagliflozin or to any of the excipients in Jardiance, because an angioedema-like reaction has occurred, and in patients undergoing dialysis.
“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 2 diabetes,” said Leonard Glass, senior vice president, global medical affairs diabetes & obesity, Lilly.
“This decision brings us one step closer in our quest to improve outcomes for this population and supports our greater commitment to advancing treatment options for people living with a variety of cardiometabolic conditions.”
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 type 2 diabetes patients with an eGFR less than 30 mL/min/1.73 m2. Jardiance is likely to be ineffective in this setting based on its mechanism of action.