Cosmetic Filler Wins US Panel Support for HIV-related Lipoatrophy

A U.S. advisory panel on Thursday backed an injectable treatment that helps restore facial lipoatrophy associated with HIV infection, but warned against its use as a general cosmetic aid.

The panel unanimously voted to recommend that the Food and Drug Administration approve Sculptra, made by Aventis subsidiary Dermik Laboratories. The agency usually follows the advice of its experts.

But some medical experts say Sculptra will become a popular wrinkle treatment among the general population.

While the panel said the FDA should allow use of the synthetic polymer in HIV patients, many expressed concern there was not enough data to condone its use as a general cosmetic treatment for patients without HIV who want a younger look.

"Twenty-four hours after this is available, it's going to be used off-label," said panelist Dr. Neal Penneys.

Sculptra is already marketed in Europe as a wrinkle-filler under the name New-Fill and is used in more than 30 countries.

03/29/04