Novo Nordisk’s Liraglutide Set For March 2009 PDUFA
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase II study of once-weekly GLP-1 analog is under way, with results due next year.
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Novo Nordisk liraglutide delayed
FDA's review of Novo Nordisk's diabetes agent liraglutide will probably be delayed "by a couple of months" for an advisory committee review of the GLP-1 analogue, the company reports Sept. 5. The March 2, 2009 meeting is three weeks before liraglutide's user fee date (1"The Pink Sheet" DAILY, Aug. 8, 2008). Liraglutide may be subject to extra scrutiny after recent reports of pancreatitis from Amylin/Lilly's GLP-1 Byetta (exenatide