FDA approves Sculptra
August 05 2004 12:00 AM ET
A substance long used to make dissolvable stitches now can help plump up faces left sunken and gaunt by HIV, the Food and Drug Administration ruled Tuesday. The FDA's approval of Sculptra, an injectable filler, marks the first treatment specifically for the loss of facial fat common among HIV patients.
Called lipoatrophy, in severe cases patients are left with sunken-looking cheeks and eyes that can dramatically affect quality of life. No one is sure what causes the fat loss, although it seems to be associated with anti-HIV therapies. Estimates are that 20% to 50% of HIV patients experience some degree of lipoatrophy.
Sculptra is a form of a polymer used for decades to create dissolvable stitches. In its injectable form, it has been used as a wrinkle filler in Europe since 1999. In approving U.S. sales the FDA cited research showing Sculptra improved facial shape and appearance when injected into sunken areas of HIV patients' faces. While some patients' effects may last two years, the substance can break down, so repeat treatments may be necessary, the FDA cautioned. Side effects include skin nodules, redness, swelling, and bruising at the injection site.
Studies to date have primarily included white men. As a condition of approval, the FDA told Sculptra maker Dermik Laboratories to track 100 patients for five years--including at least 30 women and 30 patients with dark skin--to monitor long-term effects.
The FDA said Sculptra should be used only by health-care providers familiar with Dermik's training materials and warned that the drug has not been approved for wider cosmetic use such as wrinkle filling. Dermik, the dermatology division of drug giant Aventis, refused to reveal the drug's planned price. (AP)