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FDA NEWS RELEASE
For Immediate Release: Nov. 10, 2010
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FDA approves Egrifta to treat Lipodystrophy in HIV patients
The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.
Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”
Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.
Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.
The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.
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