麻豆传媒

Once-weekly exenatide extended-release (Bydureon BCise) is now FDA approved for children with type 2 diabetes ages 10 and up, .

Already approved in adults, the expanded label now holds an indication for pediatric patients ages 10 to 17 with type 2 diabetes as an adjunct to diet and exercise. This approval makes the agent the first once-weekly GLP-1 receptor agonist for a pediatric population.

Support for the new approval was based on an 82-person phase III BCB114 trial, in which participants on treatment saw a 0.25% decrease in HbA1c versus an average 0.45% increase for those on placebo (between-group difference -0.85%; P<0.05).

In data from the trial presented at the 2021 American Diabetes Association virtual meeting, non-significant trends toward better outcomes for fasting glucose (-21.6 mg/dL, 95% CI -49.0 to 5.7), body weight (-1.22 kg, 95% CI -3.59 to 1.15), and systolic blood pressure (-2.8 mmHg, 95% CI -8.0 to 2.4) were observed with active exenatide.

The agent showed a similar safety profile as compared with adult patients, with the most common adverse events being injection-site nodules (10.5%) and nausea (8.2%).

"The U.S. FDA approval is an important milestone for the treatment of children with type 2 diabetes," said lead investigator William Tamborlane, MD, of Yale School of Medicine in New Haven, Connecticut, in a statement. "Bydureon BCise brings an important new therapeutic option to physicians caring for children with this chronic disease that can lead to serious long-term issues if not adequately treated."

Extended-release exenatide comes in a 2-mg subcutaneous injection administered once every 7 days at any time of day and with or without a meal. The dose should also be administered immediately after preparation. The product is available as 2-mg single-dose pens or as 2-mg single-dose vials in a single-dose tray.

The agent is not recommended as first-line therapy for type 2 diabetes and should not be used in patients with type 1 diabetes, or in conjunction with other exenatide products.

The treatment also carries a warning regarding an increased incidence of thyroid C-cell tumors and is contraindicated for patients with a personal or family history of multiple endocrine neoplasia syndrome type 2.

Prior to this new approval, the only non-insulin options for adolescents with type 2 diabetes were metformin and once-daily liraglutide (Victoza), which was approved in 2019.

In 2005, injectable exenatide () became the first GLP-1 receptor agonist to be approved for type 2 diabetes, for an adult population. Extended-release exenatide () was later approved in 2014, and a revised formula -- extended-release injectable suspension () in a continuous-release microsphere delivery system -- was okayed in 2017.

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