FDA approves tesamorelin for HIV patients with lipodystrophy

FDA approves tesamorelin for HIV patients with lipodystrophy

December 10, 2010

Canada-based Theratechnologies announced that FDA has approved tesamorelin (Egrifta) to treat HIV patients with lipodystrophy. The condition is associated with many antiretroviral drugs used to treat HIV.

Canada-based Theratechnologies announced that FDA has approved tesamorelin (Egrifta) to treat HIV patients with lipodystrophy. The condition is associated with many antiretroviral drugs used to treat HIV.

Tesamorelin is the first FDA-approved treatment for lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. It is a growth hormone releasing factor drug that is administered in a once-daily injection.

FDA’s approval of tesamorelin was based on 2 clinical trials involving 816 HIV-infected adults with lipodystrophy and excess abdominal fat. In both studies, patients treated with tesamorelin experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving a placebo. Some patients using tesamorelin reported improvements in their self-image.