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AstraZeneca: FDA Approves BYDUREON For Expanded Use - Quick Facts

AstraZeneca (AZN.L) announced the US FDA has approved BYDUREON (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes with inadequate glycemic control. BYDUREON is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.

The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of BYDUREON or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with type 2 diabetes.

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