Exenatide extended release  has now been accorded US FDA approval for use in children aged ≥10 years with type 2 diabetes in addition to diet and exercise to improve glycemic control. This makes it the second glucagon-like peptide-1 receptor agonist approved for use in pediatric type 2 diabetes, after liraglutide, which was approved in 2019.

This injectable formulation is not recommended as a first treatment option for patients whose disease is not adequately controlled through diet and exercise. It is not be used for children with type 1 diabetes.

Exenatide extended-release has earlier been approved to treat adults with type 2 diabetes.

A boxed warning has been added to prescribing information about the increased risk of thyroid C-cell tumors. The FDA has cautioned that patients with family history of medullary thyroid carcinoma, patients with multiple endocrine neoplasia syndrome type 2 or a history of drug-induced immune mediated thrombocytopenia or those with previous hypersensitivity to exenatide or any of its components should avoid the therapy.

While the overall side effects reported (injection site reactions, headaches and gastrointestinal discomfort) were similar to those seen in adults, warnings about hypoglycemia when used with insulin or insulin secretagogues, acute kidney injury, gastrointestinal disease, immunogenicity, allergic reactions (such as anaphylaxis  and angioedema) and drug-induced immune-mediated thrombocytopenia have been included.

Type 2 diabetes mellitus was earlier perceived as adult-onset diabetes. But, its prevalence in children and adolescents has increased in recent years. Therefore, it is important to screen children at high risk such as positive family history of type 2 diabetes mellitus and/or clinical features of insulin resistance (such as hypertension, dyslipidemia, polycystic ovarian syndrome, or acanthosis nigricans).

Type 2 diabetes mellitus is emerging as a new clinical problem within pediatric practice. Recent reports indicate an increasing prevalence of type 2 diabetes mellitus in children and adolescents around the world in all ethnicities, even if the prevalence of obesity is not increasing any more. Therefore, a screening seems meaningful especially in high risk groups such as children and adolescents with obesity, relatives with type 2 diabetes mellitus, and clinical features of insulin resistance (hypertension, dyslipidemia, polycystic ovarian syndrome, or acanthosis nigricans).

The American Diabetes Association (ADA) Standards of Medical Care in Diabetes—2021 recommends risk-based screening for prediabetes and/type 2 diabetes after the onset of puberty or after 10 years of age, whichever occurs earlier, in children and adolescents with overweight (BMI ≥85th percentile) or obesity (BMI ≥95th percentile) and who have one or more risk factor for diabetes.

Metformin is the only oral anti-diabetic drug approved for use in children with type 2 diabetes, while the approved injectables include insulin, liraglutide and now exenatide.

(Source: FDA OKs extended-release exenatide for children with type 2 diabetes - Medscape - Jul 23, 2021; https://content.govdelivery.com/accounts/USFDA/bulletins/2e98d66; ADA Standards of Medical Care 2021)