The FDA approves Egrifta, the first drug to treat HIV patients with lipodystrophy

The Food and Drug Administration on Wednesday approved Egrifta, the first drug designed specifically to treat lipodystrophy in HIV-positive patients undergoing antiretroviral therapy. In lipodystrophy, fat deposits accumulate in different areas of the body, most notably around the liver, stomach and other abdominal organs. The problem is associated primarily with protease inhibitors, the family of drugs that made cocktails of antiretroviral drugs highly successful.

Egrifta, known generically as tesamorelin, is a growth hormone-releasing factor that is administered in a once-daily injection. In two clinical trials enrolling 816 HIV-positive adult men and women with lipodystrophy, 543 patients received the drug over 26 weeks while the rest received placebos. Those patients receiving the drug showed a greater reduction in abdominal fat as measured by CT scans. Some patients reported improvements in their self-image. It has not been determined whether the drug lowers the risk of heart disease.

The most commonly reported side effects included joint pain, skin redness and rash at the injection site, stomach pain, swelling and muscle pain.

Egrifta was developed by Theratechnologies Inc. of Montreal and will be marketed in the United States by EMD Serono of Rockland, Mass.