Therapy Areas: Diabetes
FDA okays Amylin's Type 2 diabetes treatment BYDUREON
30 January 2012 - US Amylin Pharmaceuticals Inc (NASDAQ:AMLN) and Irish Alkermes plc (NASDAQ:ALKS) said on Friday that the once-weekly treatment for Type 2 diabetes, BYDUREON (exenatide extended-release for injectable suspension), has been approved in the US.

The medicine 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 utilises Alkermes' technology for long-acting medications to provide a controlled release of exenatide.

The US Food and Drug Administration (FDA) approval was based on safety and efficacy data from the DURATION clinical trial programme, in which treatment with BYDUREON led to improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTA (exenatide) injection, a twice-daily form of exenatide.
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