New drug to treat HIV patients with lipodystrophy
The US Food and Drug Administration or FDA has approved a new drug Egrifta (tesamorelin) for the treatment of HIV patients with lipodystrophy, a condition where excess fat develops mostly in the liver, stomach, and other abdominal organs.
Egrifta is noted as a growth hormone releasing factor (GRF) drug that is administered once-daily.
"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."
Researchers are yet to find if the drug helps reduce risk of cardiovascular diseases.
The drug was scrutinized after evaluating 816 HIV patients with lipodystrophy. 543 of them took Egrifta during a 26-week, placebo-controlled period. As against those receiving placebo, those who took Egrifta experienced greater reductions in abdominal fat.
However side effects such as joint pain, skin redness, rash, were reported while taking injections. Some of them also complained of stomach ache, swelling and muscle pain at later stages. Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
The drug was made by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.