By Michael Dabaie

 

AstraZeneca said its Bydureon BCise, or exenatide extended-release, was approved in the U.S. for the treatment of type 2 diabetes in pediatric patients ages 10 years and older.

The U.S. Food and Drug Administration approval was supported by the results of the BCB114 Phase III trial in youth with type 2 diabetes. which showed on top of standard of care exenatide extended-release significantly improved glycemic control compared to placebo in pediatrics.

Bydureon BCise was first approved in the U.S. in October 2017 as a once-weekly single-dose autoinjector device to improve glycemic control for adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise. It was also approved for use in the European Union in August 2018.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

July 23, 2021 08:26 ET (12:26 GMT)

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