Sculptra

Sculptra is a proprietary formulation of poly-L-lactic acid (PLLA) that is an FDA-approved dermal filler manufactured by Dermik Laboratories, which conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis (of Sanofi-Aventis).

PLLA was approved by the FDA on August 3, 2004, for the treatment of facial fat loss (also called facial lipoatrophy). According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with HIV who take anti-HIV drugs may develop lipoatrophy. Sculptra was subsequently approved by the FDA for use with non-HIV patients with wrinkles, despite substantial complications reported to the FDA.

• Lipodystrophy