FDA clears Bydureon for Type 2 Diabetes
Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) indicated for type 2 diabetes.
Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings.
Bydureon uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.
The FDA decision was backed by safety and efficacy data from the Duration clinical trial program, in which treatment with Bydureon resulted in improvements in glycemic control with just one dose per week.
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