FDA Advisory Panel Recommends Approval for Product To Treat Sunken Facial Features of HIV/AIDS Patients
An FDA advisory panel on Thursday unanimously recommended for approval a treatment from French drug maker Aventis called Sculptra that is used to treat HIV/AIDS patients' sunken facial features, sometimes referred to as facial lipoatrophy or facial wasting, the Wall Street Journal reports. The product will need to receive final FDA approval to be marketed in the United States, but FDA usually follows the recommendations of its advisory panels, according to the Journal (Wall Street Journal, 3/26). The panel said that a treatment for the HIV-related facial wasting disorder is "woefully needed" and noted studies that have shown Sculptra is safe and effective for use by people living with HIV/AIDS, according to Dow Jones/Journal (Middleton, Dow Jones/Wall Street Journal, 3/25). Sculptra already is "popular" in Europe for cosmetic use, the Journal reports (Wall Street Journal, 3/26). Sculptra currently is marketed in Europe as a wrinkle treatment called New-Fill and is used for cosmetic purposes in more than 30 countries, according to Reuters (Reuters, 3/25).
Concerns Over Off-Label Use
Panel members expressed concern that after the product receives approval in the United States, doctors could prescribe the treatment for off-label use to HIV-negative people for cosmetic purposes, Dow Jones/Journal reports (Dow Jones/Wall Street Journal, 3/25). "Twenty-four hours after this is available, it's going to be used off-label," panel member Dr. Neal Penneys said (Reuters, 3/25). Therefore, panel members recommended that FDA clearly restrict the treatment's use to HIV-positive people, require training for physicians and obtain data on its use in a wider population because the trials presented to the panel included primarily white males (Wall Street Journal, 3/26). Aventis is working with FDA to finalize plans for studies on the cosmetic uses of Sculptra, according to Dow Jones/Journal (Dow Jones/Wall Street Journal, 2/25).