Bydureon BCise (exenatide extended-release), an injected drug taken once weekly to treat type 2 diabetes, is now approved for children ages 10 and older by the U.S. Food and Drug Administration, according to an announcement from its manufacturer, AstraZeneca.
This approval means that Bydureon BCise is the first extended-release drug in the class of GLP-1 receptor agonists that is available for use in youths with type 2. It comes after the announcement of encouraging results from a clinical trial involving people ages 10 to 17, showing that when taken in addition to standard-of-care treatments, the drug resulted in significantly improved blood glucose control compared with a placebo (inactive injection). Other than insulin, the only other approved drug treatments for type 2 diabetes in youths ages 10 to 17 are metformin — the first-line oral drug for type 2 — and Victoza (liraglutide), a GLP-1 receptor agonist that is typically injected once daily.
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Cases of type 2 in children and adolescents increasing worldwide
The announcement notes that while type 2 diabetes in children and adolescents was once considered rare, documented cases in this population have been increasing around the world since the mid-1990s. This rise has been particularly pronounced in the United States, and has occurred along with an increase in overweight and obesity in the youth population.
FDA approval of Bydureon BCise “is an important milestone for the treatment of children with type 2 diabetes,” said William Tamborlane, MD, an investigator in the latest clinical trial of the drug, adding in the announcement that the approval “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.”
Bydureon BCise comes as a single-dose autoinjector device, and was first approved in the United States as a once-weekly treatment for adults with type 2 diabetes in October 2017. It is intended for people whose blood glucose control is inadequate while taking one or more oral drugs, in combination with lifestyle measures like diet and exercise. In the latest trial of the drug in youths with type 2, after 24 weeks of treatment, the group that received Bydureon BCise had an A1C level (a measure of long-term blood glucose control) that was 0.85% lower, on average, compared with the group that received a placebo, as noted in a Healio article on the approval.
“The Phase III data that supported this approval demonstrated the safety and tolerability of exenatide extended-release in younger patients,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D for AstraZeneca, in the announcement, adding that the drug’s safety profile appears to be similar in this younger population to what it is in adults. The safety and effectiveness of Bydureon have not been evaluated or demonstrated in children younger than 10 years old.