The FDA has approved exenatide extended-release for pediatric patients with type 2 diabetes, according to a release from the manufacturer.

This marks the first approval for a once-weekly glucagon-like peptide-1 receptor agonist, which along with diet and exercise can improve glycemic control,  for pediatric patients. 

The FDA based its approval on results from the phase 3 BCB114 trial findings. The trial included 82 patients between the ages of 10 and 18 who were randomized to exenatide or placebo.

The primary efficacy endpoint of the trial was change in HbA1c from baseline to week 24. The 58 patients assigned exenatide achieved greater mean change in HbA1c from baseline: -0.25%, from baseline mean A1C of 8.13%. Patients treated with placebo had a mean increase in A1C of 0.45% from a mean baseline A1C of 8.28% (P < 0.05).

The study’s International Coordinating Investigator William Tamborlane, MD, from the Yale School of Medicine called the approval “an important milestone in the treatment of children with type 2 diabetes.” 

“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,” Tamborlane added in the release.

During the trial, adverse reactions reported were similar to what has been seen in adults taking the medication. The release noted that the safety and effectiveness of the treatment have not been established in patients under 10. 

Exenatide extended-release was previously approved by the FDA and European regulators as a treatment along with diet and exercise for adults with type 2 diabetes whose blood glucose is uncontrolled with one or more medications.