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Approval of Egrifta (tesamorelin) to treat lipodystrophy
On November 10, 2010, the Food and Drug Administration 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 (vsceral body fat). The condition is associated with many antiretroviral drugs used to treat HIV. Egrifta was approved to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy.
Egrifta, the first FDA-approved treatment for lipodystrophy, is a synthetic growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
The presence of excess visceral fat accumulations associated with this condition may contribute to other health problems as well as affect a patient’s quality of life.
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 (15 - 17%) 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.
FDA is requiring a long-term observational safety study of at least 10 years duration comparing patients with HIV-associated lipodystrophy and excess abdominal fat treated with Egrifta to a similar group of patients not treated with Egrifta to assess potential safety concerns associated with long-term administration of Egrifta, including but not limited to the occurrence of glucose intolerance/diabetes mellitus,hypersensitivity reactions, malignancies, liver abnormalities, kidney abnormalities, diabetic retinopathy, and major adverse cardiovascular events.
FDA is also requiring the company to conduct a long-term (minimum 3 year), placebo-controlled study in patients with Type 2 diabetes mellitus who have HIV-lipodystrophy and excess abdominal fat to specifically evaluate risk of retinopathy (a specific eye disease in diabetics).
Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Massachusetts-based EMD Serono.
Product labeling for Egrifta will be made available soon on Drugs@FDA.
Office of Special Health Issues
Food and Drug Administration
Division of Antiviral Drug Products
Food and Drug Administration