June 6, 2023

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FDA approved Bydureon BCise for children with type 2 diabetes!

FDA approved Bydureon BCise for children with type 2 diabetes!



FDA approved Bydureon BCise for children with type 2 diabetes!  New medicine for children with type 2 diabetes! The US FDA approves Bydureon BCise (exenatide sustained-release formulation): the first weekly GLP-1 RA preparation for pediatric patients!

AstraZeneca Type 2 Diabetes Bydureon BCise Exenatide Extended Release Child.

Recently, AstraZeneca’s diabetes drug Bydureon BCise (exenatide sustained-release formulation) was approved by the U.S. Food and Drug Administration (FDA). The drug is a once-a-week injection suspension used as an aid to diet and exercise. The method is used to treat pediatric patients (10-17 years old) with type 2 diabetes (T2D) to improve blood sugar control. It is worth mentioning that this is the first time that the US FDA has approved a weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in pediatric patients of this age group.

Bydureon BCise (exenatide sustained-release formulation) was first approved in the United States in October 2017. As a once-a-week single-dose auto-injector, it is suitable for taking one or more doses in addition to controlling diet and strengthening exercise. Adult patients with T2D who are still unable to control their blood sugar levels with oral medications to improve blood sugar control. In the European Union, Bydureon BCise was approved in August 2018.

Nearly 40 years ago, T2D was considered rare in children. However, since the mid-1990s, the global incidence of T2D among children has been increasing due to the increase in the proportion of overweight or obese children, especially in the United States.

The pediatric approval is based on the results of the Phase 3 trial of BCB114 in T2D pediatric patients aged 10 to 18 years old. Data show that in pediatric patients of this age, compared with placebo, the extended-release exenatide significantly improved blood sugar control.

This is the first weekly GLP-1 RA clinical trial completed in the T2D pediatric population. Since the only non-insulin options for T2D adolescents are metformin and liraglutide (liraglutide, once a day), this approval marks an important progress in the treatment of diabetes in this specific population.

Mene Pangalos, Executive Vice President of Research and Development of AstraZeneca Biopharmaceuticals, said: “This decision is an important milestone to care for this young patient population by providing a convenient, weekly treatment option. Support this approval Phase 3 data shows that the safety and tolerability of extended-release exenatide in young patients are similar to the proven safety of the drug in adult patients.”

William Tamborlane, an international coordinating researcher for the Phase 3 trial of BCB114 and Ph.D. of Pediatrics at Yale School of Medicine, said: “The approval of the US FDA is an important milestone in the treatment of type 2 diabetes in children. Doctors for children with this chronic disease have brought an important new treatment option, and if not treated properly, the disease can cause serious long-term problems.”

BCB114 is a 24-week, randomized, double-blind, placebo-controlled Phase 3 trial with a 28-week open-label expansion period. T2D pediatric patients enrolled in the study, aged 10-17 years (N=82), diet and exercise therapy alone, or combined therapy with a stable dose of oral hypoglycemic drugs and/or insulin, still cannot adequately control blood sugar. In the study, patients were randomly assigned to receive the extended-release exenatide 2 mg or placebo. The primary efficacy endpoint of the trial is the change in glycosylated hemoglobin (HbA1c) from baseline inspection to week 24.

The results showed that compared with the placebo group (n=24), the exenatide sustained-release treatment group (n=58) patients had a significantly greater average change in HbA1c from baseline (-0.25%, baseline A1C was 8.13% vs. +0.45%, baseline A1C is 8.28%; p<0.05).

In general, the adverse reactions observed in the pediatric population are consistent with those observed in the adult population. The safety and effectiveness of extended-release exenatide in children under 10 years of age have not been determined.


(source:internet, reference only)

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