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FDA Advisory Panel Punts On LIRAGLUTIDE

Posted Apr 09 2009 7:13pm
Novo Nordisk's LIRAGLUTIDE has been shown to be highly effective in treating Type 2 diabetes. In addition, it appears, from previous studies, to be a bit more effective, and better tolerated, than BYETTA. Last, but not least, it's a once-daily injection.

However, it has been reported to cause thyroid
C-cell tumorsin rodent studies. A review of the literature suggests a great predominance of C-cell tumors occurring in animals. Should this association, with a tumor often taking decades to develop, lead to a thumbs-down?

That's the confusing and almost unanswerable question Food and Drug Administration regulators find themselves facing after a federal advisory panel on Thursday split its vote on whether to approve Novo Nordisk's promising new diabetes drug.

Novo Nordisk reports no evidence of this problem in human studies to date, but they cannot fully rule out the problem. The panel deadlocked six to six on whether liraglutide should be approved.

The 13th doctor on the panel was so confused by the issue he abstained on the key vote.

No, his name was not Vinnie Barbarino


The financially-slanted Forbes article ishere.

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