AstraZeneca’s Bydureon BCise (exenatide extended-release) Receives the US FDA’s Approval for the Treatment of Type2 Diabetes

July 23, 2021 Auto Bot regulatory 0

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  • The approval is based on results of the P-III BCB114 trial evaluating Bydureon BCise (qw, injectable suspension) vs PBO in 82 patients aged b/w 10 – 18 yrs. with T2D as an adjuvant to diet and exercise alone or in combination with a stable dose of oral antidiabetic agents and insulin for 24 wks.
  • The results demonstrate a greater mean change in HbA1c from baseline, improved glycemic control while safety and tolerability of Bydureon BCise in younger patients was similar to the proven safety profile in adults
  • Bydureon BCise (exenatide extended-release) is the 1st GLP-1 RA treatment option for pediatric patients with T2D in the US & also approved for use in the EU in Aug’18

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