To Approve or Not to Approve?

In January, we wrote about the tightening of standards by the Food and Drug Administration (FDA) in its approval of new drugs for Type 2 diabetes (see “FDA: Stifler or Savior?”). When the FDA made this change, its main concern was whether new drugs increased the risk of heart disease, in light of a 2007 study that linked the drug rosiglitazone (brand name Avandia) with an increased risk of heart attack. The leader of that study, Steven Nissen, MD, of the Cleveland Clinic, was a major proponent of the new FDA guidelines.

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Now, a prominent diabetes drug may be held up because of a different risk. The new drug by Novo Nordisk, liraglutide, has been associated with thyroid tumors in tests of rats and mice. While Novo Nordisk claims there is no evidence that the drug increases the risk of thyroid tumors in humans, earlier this month an FDA advisory panel of outside experts split its vote 6-6 on whether the tumor evidence should prevent liraglutide from being approved. The FDA can now decide whether to approve liraglutide or to request additional studies.

Liraglutide shows many potential advantages over existing drugs for Type 2 diabetes, including weight loss and the need to take it only once a day. It is in the same class of injectable drugs, GLP-1 agonists and analogs, as exenatide (brand name Byetta).

What do you think — how cautious should the FDA be when a problem is found in animal but not human trials? What should the FDA do when its advisory panel is evenly divided? And knowing what you know, how would you feel about taking liraglutide? Leave a comment below!

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