Shots:

• 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

  | Ref: Businesswire | Image: The Scientist Magazine