- The FDA has approved AstraZeneca Plc's AZN Budureon BCise (exenatide extended-release), once-weekly injectable suspension for type 2 diabetes (T2D) in pediatric patients (10 to 17 years) as an adjunct to diet and exercise.
- The approval was supported by the positive results of the BCB114 Phase 3 trial, which showed that on top of standard of care, exenatide extended-release significantly improved glycemic control compared to placebo in pediatrics.
- This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D, the Company said in the press release.
- Price Action: AZN shares are up 0.21% at $58.37 during the premarket session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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