Egrifta receives regulatory approval
SILVER SPRING, Md. The Food and Drug Administration has approved a drug for treating excess fat development in patients with HIV, the agency said Thursday.
The FDA approved Egrifta (tesamorelin) for treating HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, such as the abdominal organs. The condition is often a side effect of the retroviral drugs used to treat the disease.
The drug, the first FDA-approved treatment for the condition, is a growth hormone-releasing factor administered daily by injection. Montreal-based Theratechnologies developed the drug, while EMD Serono, the U.S. subsidiary of German drug maker Merck KGaA, markets it.
“The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said. “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.”