Summaries of health policy coverage from major news organizations
FDA Approves Sculptra Treatment for Facial Wasting in HIV-Positive People
FDA on Tuesday approved French drug maker Aventis' Sculptra to treat sunken facial features, a condition known as facial lipoatrophy or facial wasting, in HIV-positive people, Reuters reports (Heavey, Reuters, 8/3). The condition, which is thought to be a side effect of antiretroviral drug therapy, results in the loss of fat beneath the skin leading to sunken cheeks and eyes and indentations on the face (Associated Press, 8/3). About 20% to 50% of HIV-positive people experience some form of the condition (Philadelphia Inquirer, 8/4). Although the condition does not pose a physical danger, it can lead to depression and other psychological conditions, Reuters reports (Reuters, 8/3). Sculptra currently is marketed in Europe as a wrinkle treatment called New-Fill and is used for cosmetic purposes in more than 30 countries (Kaiser Daily HIV/AIDS Report, 3/29). FDA in its approval of Sculptra -- which is made from the same material as dissolvable stitches -- cited studies showing that the injectable treatment improved facial shape and appearance and said its effects may last as long as two years (Orlando Sentinel, 8/3). As a condition of approval, Dermik Laboratories, the Aventis unit that is marketing the drug, must study the long-term effects of the drug in 100 patients -- including at least 30 women and at least 30 patients with dark skin -- for five years, according to FDA (Saranow/Efrati, Wall Street Journal, 8/4).
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