Expanded use based on results from 28-week DURATION-7 study

 

AstraZeneca announced that the Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) as an add-on to basal insulin in adults with type 2 diabetes who have inadequate glycemic control.

 

Bydureon is currently indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. The expanded approval was supported by data from the DURATION-7 study which compared Bydureon vs placebo as add-on therapy to insulin glargine, with or without metformin, in adults with type 2 diabetes. Patients with a mean baseline HbA1c of 8.5% who received Bydureon experienced a 0.9% mean HbA1c reduction vs 0.2% in the placebo arm (difference 0.6%; P<0.001).

 

Also, more patients in the Bydureon arm achieved HbA1c <7.0% compared with those in the placebo arm (32.5% vs  7.0%). No new safety signals were observed in the study; the rate of overall hypoglycemia was similar between the treatment arms (29.7% vs 29.0%). Nausea, diarrhea, headache, vomiting, constipation, injection-site pruritus, injection-site nodule, and dyspepsia were the most commonly reported adverse events.

 

Exenatide is a glucagon-like peptide 1 (GLP-1) receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. It is available as a 2mg strength powder for subcutaneous (SC) injection after reconstitution.

 

From Astra.zeeneca press relerase

 

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