FDA approves once-weekly exenatide for children with type 2 diabetes
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The FDA approved the GLP-1 receptor agonist exenatide for children aged 10 to 17 years with type 2 diabetes, the first once-weekly injectable approved for pediatric use in the United States, according to an industry press release.
The approval of exenatide extended release (Bydureon BCise, AstraZeneca) comes after positive phase 3 data, presented at the American Diabetes Association Scientific Sessions and reported by Healio, demonstrated adolescents with type 2 diabetes were more likely to achieve HbA1c targets after 24 weeks of once-weekly exenatide compared with placebo. Researchers also noted trends observed toward decreased fasting plasma glucose and reduced body weight.
“The U.S. FDA approval is an important milestone for the treatment of children with type 2 diabetes,” William Tamborlane, MD, professor and chief of pediatric endocrinology at Yale School of Medicine in New Haven, Connecticut, and the international coordinating investigator of the exenatide trial, said in the release. “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.”
For the phase 3 study, 83 adolescents aged at least 10 years with type 2 diabetes, with or without insulin or sulfonylurea therapy, were randomly assigned 5:2 once-weekly exenatide 2 mg (n = 59) or placebo (n = 24) for 24 weeks, followed by a 28-week, open-label extension phase. Primary efficacy endpoint was change from baseline HbA1c at week 24; secondary efficacy endpoints were changes in fasting glucose, body weight and systolic blood pressure. Researchers also assessed the frequency of adverse events.
At 24 weeks, once-weekly exenatide was superior to placebo in lowering HbA1c (least squares mean change, 0.36% vs. 0.49%, respectively), with a between-group difference of 0.85 percentage points (P = .012).
Researchers also noted nonsignificant least squares mean differences from baseline to 24 weeks favoring exenatide for fasting glucose (21.6 mg/dL; 95% CI, 49 to 5.7), systolic BP (2.8 mm Hg; 95% CI, 8 to 2.4) and body weight (1.22 kg; 95% CI, 3.59 to 1.15).
There were low rates of hypoglycemia during the trial, despite insulin use, and good gastrointestinal tolerability, even in the absence of exenatide titration when stating treatment. The trial was the first for a once-weekly GLP-1 receptor agonist in a pediatric population with type 2 diabetes.
“This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option,” Mene Pangalos, executive vice president, AstraZeneca BioPharmaceuticals R&D, said in the release. “The phase 3 data that supported this approval demonstrated the safety and tolerability of exenatide extended-release in younger patients was similar to the proven safety profile of this medicine in adults.”
Exenatide extended-release was approved in the U.S. in October 2017 as a once-weekly, single-dose autoinjector device for adults with type 2 diabetes whose glucose level remains uncontrolled with one or more oral diabetes medicines in addition to diet and exercise. It was also approved for use in the European Union in August 2018.
Perspective
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The FDA’s approval of once-weekly exenatide, a GLP-1 receptor agonist, for adolescents with type 2 diabetes comes at an important time for the treatment of obesity and type 2 diabetes with analogues of naturally occurring gut hormones. GLP-1 analogues have been used in the treatment of obesity and type 2 diabetes in adults since 2005, when the first — daily exenatide — was approved.
The gut hormone GLP-1 was discovered in 1985. Since then, its actions have been researched extensively, giving rise to knowledge of a complex and intertwining pathway linking obesity and type 2 diabetes in both pathophysiology and treatment.
Obesity and type 2 diabetes are rising not just in adults, but in children and adolescents, at an alarming rate. We need better treatments for adolescents that can prevent the complications of these diseases. GLP-1 receptor agonists are that set of treatments. In adults, GLP-1 receptor agonists have been linked to decreased mortality among those with diabetes and obesity, as well as prevention of sequelae, such as cardiovascular disease and stroke.
Adolescents need just as many if not more options than adults because of the importance of early treatment in the disease progression of both diseases, which is relentless and causes alarming morbidity and mortality. GLP-1 receptor agonists have a unique dual role to treat both obesity and type 2 diabetes, and these breakthrough drugs should be offered more readily to our younger population, both for their impressive efficacy and safety.
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