FDA approves exenatide extended-release for pediatric type 2 diabetes
medwireNews: The US FDA has expanded the indication for exenatide extended-release to include pediatric type 2 diabetes.
Previously approved for the treatment of adults with type 2 diabetes, the glucagon-like peptide-1 receptor agonist may now be given to children and adolescents between the ages of 10 and 17 years in combination with diet and exercise interventions.
The approval was based on the results of the phase 3 BCB114 trial, which demonstrated the efficacy and safety of exenatide extended-release relative to placebo in this population.
Exenatide extended-release is given subcutaneously, at a dose of 2 mg once per week. The label carries a boxed warning for thyroid C-cell tumors.
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