麻豆传媒

Two empagliflozin-containing treatments were FDA approved for pediatric type 2 diabetes, on Tuesday.

Once-daily empagliflozin (Jardiance) and empagliflozin/metformin hydrochloride (Synjardy) are now indicated in combination with diet and exercise for kids 10 and up.

This marks the first oral options to be approved for this indication since metformin was approved for pediatric use in 2000. Injectable GLP-1 receptor agonists, including and exenatide extended-release (Bydureon BCise), are also approved for pediatric type 2 diabetes.

"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, MD, MPH, of FDA's Division of Diabetes, Lipid Disorders, and Obesity, said in a statement. "Today's approvals provide much-needed additional treatment options for children with type 2 diabetes."

The therapies are not recommended for use in patients with severe kidney problems (eGFR less than 30 mL/min/1.73 m²) nor should they be used in patients with a prior serious allergic reaction to the drugs. They are also contraindicated in patients with type 1 diabetes, metabolic acidosis, or diabetic ketoacidosis .

Underpinning the approvals were positive findings from the . In the 157-patient study, empagliflozin (10 mg or 25 mg) significantly reduced HbA1c by 0.84% in adolescents ages 10 to 17 with type 2 diabetes compared with placebo by week 26. Empagliflozin also significantly reduced fasting plasma glucose by 35.2 mg/dL by week 26, achieving the trial's secondary endpoint.

This trial also tested linagliptin (Tradjenta) in pediatric diabetes, but the reduction in HbA1c was not statistically significant with the DPP-4 inhibitor when compared with placebo.

Similar to what's seen in adults, the most common adverse events reported in the trial among empagliflozin-treated patients were urinary tract infections and female fungal infection. Diarrhea, nausea, and upset stomach were the most common events in those treated with metformin.

Empagliflozin was first approved for adults with type 2 diabetes in 2014 and has since picked up other indications for reducing risk of cardiovascular death and hospitalization for heart failure, regardless of ejection fraction. The agent is also currently under review for a in adults based on the phase III EMPA-KIDNEY trial.

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