FDA Approves New Pediatric Medication for Type 2 Diabetes
FDA approves empagliflozin, a new class of pediatric drugs for type 2 diabetes, providing an alternative to metformin.
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- Adding to the arsenal of tools providers have to manage type 2 diabetes (T2D), the FDA has approved a new pediatric medication for managing the condition. The approval of Jardiance and Synjardy to treat T2D represents a new class of drugs to address pediatric T2D.
The drugs contain the chemical compound empagliflozin, which increases glucose excretion in the urine, reducing blood glucose levels. While Jardiance only has empagliflozin, Synjardy has empagliflozin and metformin hydrochloride, which was approved as an oral treatment for pediatric T2D in 2000.
To assess the effectiveness of empagliflozin in managing pediatric T2D, researchers conducted a double-masked, randomized, placebo-controlled trial with 157 patients between 10 and 17. Patients received empagliflozin, linagliptin (a DPP-4 inhibitor), or a placebo.
Over six months, empagliflozin improved hemoglobin A1C, decreasing it by 0.2%. Comparatively, patients in the placebo group had a 0.7% increase in hemoglobin A1C. Additionally, the data showed improvement in plasma glucose levels.
Before the most recent approval, Jardiance was approved by the FDA in 2014 to help manage T2D in adults alongside diet and exercise changes, reducing blood sugar levels and cardiovascular risks. One year later, Synjardy was approved for similar indications.
Despite being approved under priority review, the drugs come with risks. Common side effects include urinary tract infections and female fungal infections caused by empagliflozin. Additionally, side effects of Synjardy, caused by metformin, include diarrhea, nausea, and upset stomach.
Beyond the general risks of the drugs, clinical trials revealed that pediatric patients had a higher risk of hypoglycemia than adult patients taking the medication. Some contraindications exist for patients with kidney disease, severe drug allergies, metabolic acidosis, or diabetic ketoacidosis.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progresses more rapidly in children,” explained Michelle Carey, MD, MPH, associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in the FDA press release. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
