FDA Approves First Drug For HIV-Drug Side Effect
WASHINGTON - Federal health regulators have approved the first drug to eliminate excess fat that develops as a side effect of HIV treatments.
The Food and Drug Administration announced Wednesday it approved Egrifta for lipodystrophy, which causes excess fat in the liver, stomach and other abdominal organs. The condition is common in patients taking anti-viral drugs used for HIV.
Egrifta is injected once daily.
Pharmaceutical developer Theratechnologies Inc. studied its drug in more than 800 HIV patients with abdominal fat. After six months of treatment, patients taking Egrifta had significantly less fat than patients who received a placebo injection. The most common side effects reported with the drug included joint pain, skin redness and rash.
The FDA stressed in a press release that the drug has not been proven to decrease the risk of heart disease or other complications.
Egrifta was developed by Montreal-based Theratechnologies and marketed in the U.S. by Rockland, Mass.-based EMD Serono.
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