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Nov. 11, 2010 -- The FDA has approved Egrifta for the treatment of HIV lipodystrophy.
Egrifta is administered by daily injection. In clinical trials, it significantly reduced the disfiguring fat accumulation -- lipodystrophy -- that is a side effect of many AIDS drug combinations.
"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," says Curtis Rosebraugh, MD, MPH, director of the FDA's Office of Drug Evaluation, in a news release. "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."
While the drug is effective, it's not without side effects of its own. These include joint pain, redness and rash at the site of injection, stomach pain, swelling, and muscle pain. The drug may also cause increases in blood sugar.
It's not clear whether Egrifta can prevent heart disease linked to HIV lipodystrophy. But compelling testimony by AIDS patients last May led an FDA expert advisory panel to unanimously recommend approving the drug.
Egrifta was developed by Montreal-based Theratechnologies and is marketed in the U.S. by Serono.