AstraZeneca's Once-Weekly Diabetes Med Wins FDA Nod For Use In Children


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  • The FDA has approved AstraZeneca Plc's (NASDAQ: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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Posted In: BiotechNewsHealth CareFDAGeneralBriefsDiabetes