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Medical News

FDA Staff: Theratech Drug Works, but Risks Weighed

May 26, 2010

On Thursday, a Food and Drug Administration advisory panel will review the safety and efficacy of an experimental drug for reducing excess visceral abdominal fat in HIV/AIDS patients with lipodystrophy.

An estimated 200,000 to 800,000 HIV patients may have the condition, which is partly the result of using certain AIDS drugs, FDA staff said. There is no approved treatment. Excess fat from lipodystrophy can raise the risk of heart disease. It leads some patients to discontinue highly active antiretroviral therapy.


In a preliminary analysis written for the panel, FDA staff said that Egrifta (tesamorelin acetate), made by Canada-based Theratechnologies Inc., did reduce abdominal fat. However, there was an increase in diabetes among those treated, which "may affect unfavorably the potential cardiovascular benefit of this therapy."

In studies conducted by Theratechnologies, patients treated with Egrifta for one year lost about 18 percent of their abdominal fat. FDA reviewers said they gained most of it back within about three months of stopping Egrifta, which patients had been injecting into their stomachs daily. That likely means patients would have to use the drug indefinitely.

Among those treated, Egrifta was not associated with some factors that lower heart disease risk. Decreases in cholesterol, other blood fats, and waist circumference "were seen either inconsistently during the trials or were of small magnitude," FDA reviewers said. A "considerable number" of patients had insulin-like growth factor (IGF-1) "above the upper range of normal," FDA staff said. The advisory panel will need to weigh all these considerations, "especially since this treatment is anticipated to be given long-term," FDA said.

A final decision is due by July 27.

Back to other news for May 2010

Adapted from:
05.25.2010; Lisa Richwine

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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
See Also
An HIVer's Guide to Metabolic Complications
More on Egrifta (Tesamorelin)

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