FDA Approves Exenatide Expanded Indication for Type 2 Diabetes

The US Food and Drug Administration (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.

Study results demonstrated that mean HbA1c was reduced by 0.9% in the Bydureon study arm (n= 231) versus 0.2% in the placebo group (n= 229), with a between-group difference of 0.6%, in patients with a mean baseline HbA1c of 8.5%.

Additionally, 32.5% of patients in the Bydureon group reached HbA1c of <7% versus 7% of patients in the placebo group.

“The DURATION-7 study is part of the broader DURATION clinical trial program which continues to yield vital insights on the use of exenatide,” McDermott added. “With this approval, we are providing another important treatment option for health care providers to consider for patients with type 2 diabetes on basal insulin with inadequate glycemic control.”

There were no new safety findings reported.

Overall, hypoglycemia was similar between both groups (Bydureon 29.7% and placebo 29%), with no major hypoglycemia reported, however, in both groups, the same percentage (5.6%) of patients reported minor hypoglycemia.

Common adverse effects ≥5% that occurred more frequently than in comparator Bydureon clinical trials are nausea (16.9%), diarrhea (12.7%), headache (8%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%) and dyspepsia (5.1%)

The treatment was first approved by the FDA in January 2012. Bydureon BCise, a newer formulation of exenatide extended-release was approved in October 2017 for adults with type 2 diabetes uncontrolled with other oral agents.