FDA approves new medicines to treat paediatric type 2 diabetes
The US Food and Drug Administration (FDA) has announced that it has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) alongside diet and exercise to improve blood sugar control in children over the age of ten with type 2 diabetes.
The only other oral treatment for children with type 2 diabetes is Metformin, which was approved for paediatric use in 2000, so these approvals are likely to be gratefully received as they provide a new class of oral medicines for this indication.
The safety and efficacy of the two drugs was assessed in a double-blind, randomised, placebo-controlled trial including 157 patients between the ages of ten and 17 with inadequately controlled type 2 diabetes. By the end of the trial it was noted that those treated with empagliflozin experienced superior reduction in haemoglobin A1c, a measure of average blood sugar, compared to the placebo.
Common side effects in this trial remained similar to those reported in adult patients, however there was a higher risk of hypoglycaemia (low blood sugar) among paediatric patients.
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, commented: “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. Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
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