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SCULPTRA (Newfill) for HIV FACIAL LIPOATROPHY APPROVED BY FDA
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The Food and Drug Administration today, August 3, 2004, approved Sculptra,
an injectable filler to correct facial fat loss in people with human
immunodeficiency virus (HIV).
Report From FDA Hearing on Sculptra (Newfill): study review
http://www.natap/2004/HIV/032904_02.htm
Sculptra is the first such treatment approved for a condition known as
lipoatrophy, or facial wasting, a sinking of the cheek, eye and temple areas
of the face caused by the loss of fat tissue under the skin which can affect
HIV patients. FDA expedited review of the product because of its importance
in treating people living with AIDS.
Sculptra is an injectable form of poly-L-lactic acid, a biodegradable,
biocompatible synthetic polymer from the alpha-hydroxy-acid family that has
been widely used for many years in dissolvable stitches, bone screws and
facial implants.
FDA approval of Sculptra was based on data from four studies, totaling 277
HIV-positive patients with severe facial lipoatrophy. The patients, who were
all being treated with antiretroviral drugs, were primarily white males,
mostly ages 41 to 45. Patients were given three to six injections of
Sculptra at two-week intervals and were followed for two years.
Skin thickness measurements and serial photographs from clinical studies
were assessed, as well as other data submitted by the manufacturer, Dermik
Laboratories, of Berwyn, Pa. Analysis indicated that the product
significantly improved facial appearance, and was safe for restoration
and/or correction of shape and contour deficiencies resulting from facial
fat loss in patients with HIV/AIDS. Sculptra was shown to produce
significant increases in dermal thickness (up to 2 to 3 times baseline
values), adding volume to facial tissue and restoring shape to areas of the
face with fat loss.
After an initial treatment series, repeat treatments may be needed to
maintain the correction.
Most adverse events were related to the injection itself and included
nodules, redness, swelling and bruising in the injection area.
The studies also demonstrated significant improvement in quality of life,
and measures of anxiety and depression, conditions which can be associated
with lipoatrophy.
Sculptra should only be used in patients with HIV by health care providers
who are fully familiar with the product training materials provided by
Dermik and the entire product package insert. The use of the product for
other indications, such as to treat wrinkles, has not been approved by FDA.
Sculptra should not be used in anyone who is allergic to any of the
product's components.
As a condition of approval, Dermik has agreed to conduct an open-label
registry study of 100 patients for five years to evaluate Sculptra's
long-term safety. The study will include at least 30 females and 30 people
with dark skin types.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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