22 Jun 2023 • Earlier this week, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. Empagliflozin is the first and only SGLT2 inhibitor approved for this patient population.

These approvals provide a new class of oral medications to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.

• The safety and efficacy of empagliflozin in children were studied in a double-blind, randomized, placebo-controlled trial in 157 patients aged 10 to 17 years with inadequately controlled type 2 diabetes.
• The trial found that, at week 26, treatment with empagliflozin was superior in reducing hemoglobin A1c, a measure of average blood sugar, compared to placebo.
• Patients treated with empagliflozin also had reductions in fasting plasma glucose as compared to placebo.
• Common side effects in children treated with empagliflozin were generally similar to those reported in adults, except for a higher risk of hypoglycemia.

“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.” said Dr Michelle Carey, Associate director for therapeutic review for the Division of Diabetes at the US FDA.

Source: FDA | Read full story