FDA Approves Add-On Therapy for Type 2 Diabetes

The US Food and Drug Administration (FDA) has approved the once-weekly glucagon-like peptide-1 receptor agonist injectable drug Bydureon (exenatide extended-release) for adults with type 2 diabetes with inadequate glycemic control.

The drug is indicated as an adjunctive therapy to basal insulin among patients whose blood sugar remains uncontrolled on one or more antidiabetic medications, along with diet and exercise.

Bydureon was approved following the success of the 28-week DURATION-7 study. Results of the trial demonstrated that adults with type 2 diabetes who received Bydureon (n = 231) as an add-on therapy to insulin glargine, with or without metformin, experienced a 0.9% decrease in mean hemoglobin A_1c (HbA_1c), whereas adults who received placebo (n = 229) only experienced a 0.2% decrease in HbA_1c.

The most commonly reported adverse events during the trial, which occurred more frequently in the comparator group than in the Bydureon group, included nausea, diarrhea, headache, vomiting, constipation, injection-site pruritus, injection-site nodule, and dyspepsia.

No new safety findings were reported after the completion of the DURATION-7 study.

—Christina Vogt

Reference:

US FDA approves BYDUREON for use with basal insulin in patients with type 2 diabetes with inadequate glycemic control [press release]. Wilmington, DE. AstraZeneca. April 3, 2018. https://www.businesswire.com/news/home/20180403005445/en/FDA-Approves-BYDUREON-Basal-Insulin-Patients-Type. Accessed on April 3, 2018.