FDA Approves Treatment for Pediatric Patients with Type 2 Diabetes - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves Treatment for Pediatric Patients with Type 2 Diabetes

The U.S. Food and Drug Administration today approved Bydureon and Bydureon BCise (exenatide extended-release) injection to be used in addition to diet and exercise to improve glycemic control (blood sugar levels) in pediatric patients 10 years or older with type 2 diabetes. Exenatide extended-release was previously approved to treat adults with type 2 diabetes.

Exenatide extended-release is not recommended as a first treatment option for patients whose disease is not adequately controlled through diet and exercise. The medication should not be used for type 1 diabetes. Exenatide extended-release should not be used with other exenatide-containing products and it has not been studied in patients with a history of pancreatitis (inflammation of the pancreas).

Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in adults, the prevalence among younger people has been rising over the past few decades. The Centers for Disease Control and Prevention estimates that nearly 6,000 new cases of type 2 diabetes are diagnosed each year among U.S. youth aged 10-19.

Exenatide extended-release improves blood sugar levels by creating similar effects in the body as the glucagon-like peptide (GLP-1) protein in the pancreas. GLP-1 levels are often insufficient in patients with type 2 diabetes. Like GLP-1, exenatide-extended release slows digestion, prevents the liver from making too much glucose (a simple sugar), and helps the pancreas produce more insulin when needed.

The effectiveness and safety of exenatide extended-release were studied in a 24-week, double-blind, placebo-controlled study in pediatric patients 10 years or older. A total of 82 patients with type 2 diabetes was randomly assigned to receive exenatide extended-release 2 mg once a week or a placebo. The primary endpoint was reduction in hemoglobin A1c (HbA1c). HbA1c is a blood test that is routinely performed to evaluate how well a patient’s diabetes is controlled, and a lower number indicates better control of the disease. At week 24, patients receiving exenatide extended-release had an average 0.25% decrease in HbA1c, whereas patients receiving the placebo had an average 0.45% increase in HbA1c, for a total average difference of -0.70% between the two groups.

The prescribing information for this drug includes a boxed warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had, medullary thyroid carcinoma should not use the therapy. In addition, patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2 and patients who have a prior serious allergic reaction to exenatide or any of the product components should not take the therapy. Patients with a history of drug-induced immune mediated thrombocytopenia (low blood platelet count) also should not use the drug.

Exenatide extended-release carries warnings about pancreatitis; hypoglycemia (low blood sugar) when used with insulin or insulin secretagogues (insulin secretion-promoting substances); acute kidney injury; gastrointestinal disease; immunogenicity (provocation of an immune response); allergic reactions such as anaphylaxis (an acute, severe allergic reaction) and angioedema (rapid swelling beneath the skin and mucosa); drug-induced immune-mediated thrombocytopenia, which may result in serious bleeding; injection site reactions; and acute gallbladder disease. Overall, side effects were similar in adult and pediatric patients and include injection site reactions, headaches, and gastrointestinal issues.

FDA granted this application priority review. The approvals were granted to AstraZeneca.