FDA Expands Bydureon Indication in Type 2 Diabetes

The FDA approved an expanded indication for exenatide extended-release (Bydureon) for its use as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control, announced AstraZeneca.

The expanded use is based on results from the 28-week DURATION-7 study that examined the effect of Bydureon and placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D.

Bydureon, a once-weekly injectable, was approved in October for adults with T2D to improve glycemic control in those whose blood glucose remains controlled with one or more antidiabetic medications along with diet and exercise.

“Type 2 diabetes is a complex disease for patients and health care providers to manage, which is why we continue to invest in the advancement of science supporting the safety and efficacy of exenatide, even 13 years after the first exenatide formulation was introduced to the market,” Jim McDermott, PhD, vice president, US medical affairs, diabetes, AstraZeneca, said in a statement.

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