Sunday, June 03, 2012

Will liraglutide be approved by the FDA?

By Dr. Bill Quick, Health Pro Tuesday, April 14, 2009

 

Novo Nordisk claimed that "data and analyses do not suggest any treatment-related effect of liraglutide" on the development of neoplasms; the Advisory Committee agreed, unanimously supporting the approvability of liraglutide with regard to risk of papillary thyroid cancer.

 

The clear difference of opinion among the members of the Advisory Committee about the findings in animals and whether they apply to humans might be enough to persuade the FDA to hold off on approval of liraglutide, or if the FDA does decide to approve it, to add a demand in the label that physicians should obtain thyroid testing, either blood testing for calcitonin, or thyroid ultrasound studies. The FDA might also demand that more studies will be needed to be done by Novo Nordisk to investigate the thyroid situation further, and demand the studies before approving the drug, or afterwards.

 

As this is being written, we don't yet know whether the FDA will decide to approve liraglutide, and if so, with what conditions. Since it's a "me-too" drug, with no clear advantage over Byetta except once-daily dosing, it's not really a big deal either way. Unless you own stock in Novo Nordisk, of course. Or unless it's approved and you later get thyroid cancer.

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By Dr. Bill Quick, Health Pro— Last Modified: 10/11/11, First Published: 04/14/09