Obesity drugs with safety issues are as common as celebrities getting fired for saying (or tweeting) something stupid. The Food and Drug Administration wants a cardiovascular safety trial before it'll approve Orexigen's
The latest victims are Amylin Pharmaceuticals
The antibodies can bind to and inactivate the drug, which would make it fairly useless in those patients. If only a few patients are seeing the drug inactivated, it wouldn't be a major problem; the responders that don't make antibodies could overcome the data from those making antibody.
But metreleptin is pretty close to leptin, a naturally occurring hormone that tells the body to stop eating. If the antibodies are inactivating leptin, the side effects, even in a small number of patients, could be enough to derail development.
More investigation is needed before they put this one on the shelf, but investors shouldn't hold their breath. The safety bar is extremely high for obesity drugs.
Amylin's shares ended basically flat yesterday on the news. While the data to date on pramlintide/metreleptin has been fairly strong, I think investors haven't put much value on Amylin's obesity program. Bydureon, which should be back in front of the FDA in the second half of the year, is a much more important to Amylin's near-term success.
If Amylin and partners Eli Lilly
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Fool has a disclosure policy.