|
FDA
Approves Sculptra as First Therapy for HIV-related Facial Lipoatrophy
By
Ronald Baker, PhD
Following
an expedited review, the FDA on August 3, 2004 approved Sculptra,
an injectable filler, to correct HIV-related facial
lipoatrophy (fat loss), a debilitating condition
linked both to the use of antiretrovirals and to HIV infection itself.
The chief characteristics of facial lipoatrophy are a sinking of
the cheeks, eyes and temples.
Due
to the “wasted” look of the faces of individuals with lipoatrophy,
the condition often results in depression, significant loss of self-esteem
and a decline in quality of life among those affected. Sculptra will be the first FDA-approved procedure in the US
used to treat lipoatrophy.
In
the registration trial, Sculptra produced significant increases
in skin thickness, adding volume to facial tissue and restoring
shape in areas of the face with fat loss. After an initial series
of injections with Sculptra, repeat treatments may be needed to
maintain the correction. Studies have reported an improvement in
the quality of life among those treated and less of the anxiety
and depression often associated with lipoatrophy.
When
imported from Europe, the cost of enough Sculptra for two injection
sessions is approximately $400, plus a doctor’s fee of about
$200. Dermik Laboratories (Berwyn, Pa),
a subsidiary of Aventis and the manufacturer and distributor of
Sculptra in the US, has not yet announced the cost of the treatment
nor when the injectable filler will be shipped to pharmacies in
the US.
 About
Sculptra
Sculptra
(called New-Fill in Europe) is an injectable form of poly-L-lactic
acid, a biodegradable and immunologically inert synthetic polymer
that belongs to the class of resorbable biomaterials. The product
has been safely used in a variety of orthopedic and maxillofacial
applications since the mid-1990s. In 1999, regulators in the European
Union approved poly-L-lactic (PLA) New- Fill for cosmetic correction
of scars and wrinkles.
"Change
in facial appearance is one of the emotionally devastating and stigmatizing
side effects of HIV/AIDS and the drugs used to treat it,” said FDA
Acting Commissioner Dr. Lester M. Crawford. “The AIDS community
has been awaiting a product like this that can give patients a smoother,
fuller face.”
Dermik
reported on the use of Sculptra in 278, 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.
The
studies showed that the product was safe and significantly improved
facial appearance. Most adverse events were related to the injection
itself and included nodules, redness, swelling and bruising in the
injection area.
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. FDA has not approved the
use of the product for other indications, such as to treat wrinkles.
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.
It
is estimated that 900,000 to 1 million people in the United States
are HIV-positive, although about one third are not diagnosed. Some
50 percent will develop lipoatrophy. An estimated 150,000 to 350,000
patients could potentially benefit from the new treatment.
08/04/04
Source
US
Food and Drug Administration
|
