Approves Tesamorelin (Egrifta) for Management of Lipodystrophy
in People with HIV
The U.S. Food and Drug Administration (FDA) this
week approved the growth hormone releasing factor
tesamorelin (brand name Egrifta, formerly TH9507)
for treatment of lipodystrophy, or excess body fat
accumulation, in HIV positive people taking antiretroviral
therapy (ART). Developed by Theratechnologies,
the drug will be marketed in the U.S. by EMD Serono.
Clinical trials showed that tesamorelin significantly
reduced abdominal fat with fewer side effects than
human growth hormone itself, though fat returned
when the drug was discontinued.
fat accumulation or lipohypertrophy is a concern for many
people with HIV, related to both body image and increased
cardiovascular risk; it may also compromise the effectiveness
of HIV treatment by contributing to poor ART adherence.
and after picture of abdominal lipohypertrophy.
growth hormone has been shown to reduce visceral adipose tissue
(fat deep in the abdomen surrounding internal organs), but
it can lead to side effects including elevated blood glucose,
swelling, and carpal tunnel syndrome.
Tesamorelin is a synthetic growth hormone releasing factor
that stimulates the pituitary gland in the brain to secrete
more growth hormone; this indirect approach appears to maintain
more stable, natural levels. As reported
this past spring, tesamorelin decreased visceral abdominal
fat and lowered total cholesterol, and was generally well-tolerated.
Below is the text of an FDA press release describing the approval
and supporting research.
Approves Egrifta to treat Lipodystrophy in HIV Patients
November 10, 2010 -- The U.S. Food and Drug Administration
today approved Egrifta (tesamorelin) to treat HIV patients
with lipodystrophy, a condition in which excess fat develops
in different areas of the body, most notably around the liver,
stomach, and other abdominal organs. The condition is associated
with many antiretroviral drugs used to treat HIV.
Egrifta, the first FDA-approved treatment for lipodystrophy,
is a growth hormone releasing factor (GRF) drug that is administered
in a once-daily injection.
FDA recognizes the need for therapies to treat patients with
HIV-lipodystrophy," said Curtis Rosebraugh, MD, MPH,
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."
Whether Egrifta decreases the risk of cardiovascular disease
or improves compliance with antiretroviral drugs has not been
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
Product labeling information for Egrifta will be available
soon on Drugs@FDA.
Food and Drug Administration. FDA approves Egrifta to treat
Lipodystrophy in HIV patients. Press release. November 10,