FDA finally approves Bydureon

30 January 2012

There was good news on Friday for USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) and Alkermes (Nasdaq: ALKS) as the US Food and Drug Administration finally approved their Bydureon (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes.

The FDA had previously issued a complete response letter calling for additional clinical data on the drug, that was part of a marketing agreement since terminated with drug major Eli Lilly (NYSE: LLY), which received European approval for Bydureon last summer (The Pharma Letter June 22, 2011. Full rights to Bydureon are scheduled to return to Amylin by end-2013. Amylin shares jumped 15% to $14 in after-hours trading on Friday, while Alkermes rose 4.7% to $20. Trading in both companies had been halted ahead of the FDA decision.

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 will be available in pharmacies nationwide in February.

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