THURSDAY, Nov. 11 (HealthDay News) -- Egrifta (tesamorelin) has
been approved by the U.S. Food and Drug Administration to treat fat
deposits caused by HIV-related lipodystrophy. The condition may
cause fat deposits around the liver, stomach, and other abdominal
organs.
This type of lipodystrophy is believed associated with the
antiretroviral drugs used to treat HIV, the virus that causes AIDS,
the agency said in a news release.
Egrifta's safety and effectiveness were studied in two clinical
trials involving 816 men and women infected with HIV. Participants
also had lipodystrophy and excess abdominal fat. Those who received
Egrifta had a greater reduction in abdominal fat deposits as
measured by CT scan, compared with those who took a non-medicinal
placebo.
The effects of the once-daily injected drug on cardiovascular
disease haven't been evaluated, the FDA said.
The most common adverse reactions were joint pain, injection
site redness and rash, stomach pain, and muscle pain. More
participants who took Egrifta had worsening blood sugar levels than
those who didn't take the drug, the agency said.
Egrifta is marketed in the United States by EMD Serono, based in
Rockland, Mass.
More information
To learn more about this approval, visit the
FDA.