AstraZeneca: FDA backs treatment for pediatric patients with type 2 diabetes

 The US Food and Drug Administration yesterday approved Bydureon and Bydureon BCie (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.

Developed and marketed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN), exenatide extended-release was previously approved to treat adults with type 2 diabetes. First-quarter 2021 sales of Bydureon were $103 million.

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 US 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.

Carries a boxed warning

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.

https://www.thepharmaletter.com/article/fda-backs-treatment-for-pediatric-patients-with-type-2-diabetes