WEDNESDAY, June 21, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 years and older.
The approvals of Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) provide a new class of medications for pediatric type 2 diabetes. They join metformin, which has been approved for children with type 2 diabetes since 2000.
"Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children," Michelle Carey, M.D., associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA Center for Drug Evaluation and Research, said in an agency news release. "Today's approvals provide much-needed additional treatment options for children with type 2 diabetes."
Before the approval, the active ingredient in both medications was tested for safety and effectiveness in a double-blind, randomized trial that included 157 patients aged 10 to 17 years. Participants were randomly assigned to one of three treatment arms for 26 weeks. The trial revealed that at week 26, treatment with empagliflozin, the active ingredient in these medications, was superior in reducing hemoglobin A1c (HbA1c) compared with the placebo. The 52 patients treated with empagliflozin had an average 0.2 percent decrease in HbA1C compared with an average 0.7 percent increase in HbA1c in the 53 patients taking a placebo.
Side effects included a higher risk of low blood sugar levels among pediatric patients compared to placebo, regardless of whether they were taking other therapies for diabetes.
These medications are not recommended for patients with type 1 diabetes, because of an increased risk of diabetic ketoacidosis, or for those with severe kidney problems.
Approval of Jardiance and Synjardy was granted to Boehringer Ingelheim.
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