Sculptra receives approval from FDA advisory panel
March 30 2004 1:00 AM ET
The HIV facial lipoatrophy treatment Sculptra, sold overseas as New-Fill, on Friday received unanimous approval with conditions from a Food and Drug Administration advisory committee. The injectable synthetic material, manufactured and marketed by Dermik Laboratories, is designed to fill in hollow areas of the face caused by wasting associated with HIV and antiretroviral drugs used to treat the disease. The panel recommended approval of the product with the following conditions--a postapproval study, a physician training program, product use limited to HIV-positive people who have lipoatrophy, provision of product specification information, and wording changes to the proposed product label.
Clinical trials with Sculptra in people with HIV-related lipoatrophy demonstrated noticeable results that typically lasted for up to two years after the first session. Adverse effects were generally limited to the site of the injection and included temporary redness and swelling and small, typically nonvisible bumps. "The physical signs of lipoatrophy resulting from HIV infection and its associated antiretroviral therapy can be so distressing that people may discontinue life-preserving treatment," said Marcus Conant, a clinical professor at the University of California, San Francisco, Medical Center in a Dermik press release. "The FDA panel's recommendation is a critical first step toward bringing a safe and effective treatment for facial fat loss to people with HIV. Sculptra would give those patients an important treatment for long-lasting correction of facial shape and contour deficiencies."
Sculptra, a poly-L-lactic acid, is a polymer synthetically derived from natural components. It has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used as a vehicle for several sustained-release injectable medications.