AstraZeneca's Bydureon BCise Gets U.S. Approval For Type 2 Diabetes in Pediatric Patients
July 23 2021 - 8:29AM
Dow Jones News
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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