Egrifta is First FDA Approved Drug to Treat HIV-Related Lipodystrophy
HIV-associated lipodystrophy is occurs in individuals with HIV infection who are being treated with antiretroviral medications. HIV-associated lipodystrophy can occur as abnormal central fat accumulation (lipohypertrophy) or localized loss of fat tissue (lipoatrophy) or much less commonly as a mixed clinical presentation of both.
Egrifta was approved for the lipohypertrophic form of HIV-associated lipodystrophy. The abdominal accumulation of fat in this condition is most notably around the liver, stomach, and other abdominal organs.
Excess abdominal girth due to intra-abdominal fat is associated with chronic disease states, such as diabetes and cardiovascular disease. It is not known at this time whether Egrifta decreases the risk of cardiovascular disease.
"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.”
Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
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 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.
Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.
For more information:
FDA: HIV and AIDS Activities