Byetta gets new indication, new warnings

It's a good news, bad news sort of day for Amylin Pharmaceuticals and Eli Lilly. First the good: The companies' Byetta drug got the FDA nod as a standalone treatment for type 2 diabetes patients; previously, Byetta was approved only as an add-on to other diabetes meds. Now, the drug can be marketed as a first-line treatment for the disease, which continues to grow in incidence worldwide.

Now the bad: Along with its new indication, Byetta gets stronger safety warnings. New labeling warns that patients using Byetta have died of pancreatitis. Amylin maintains that the evidence doesn't prove that Byetta caused the inflammation: "The data still do not support a causal relationship between Byetta and pancreatitis," Medical Director Ken Wilhelm told Bloomberg. "That said, it's an important safety isue and we continue to work diligently to explore the potential relationship."

The new labeling also offers strong warnings to patients with severe kidney problems, saying that those people should not take Byetta. In addition, the drug should be "used with caution" in people who have had a kidney transplant, the new label states.

As you know, the reports of pancreatitis in Byetta patients already have hit sales of the drug. Amylin's 2008 Byetta revenues dropped by 7.7 percent; at the time that those sales were reported, analysts said that they were closely watching the labeling negotiations, anticipating that the warning language would affect sales one way or another. No word yet on whether the new labeling is less or more severe than analysts had expected; for that, we'll have to wait and see.

- check out the release from Amylin
- read the Reuters news
- see the story from Bloomberg