- 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
Click here to read full press release/ article | Ref: Businesswire | Image: The Scientist Magazine