Aventis applies for FDA approval of lipoatrophy treatment
February 10 2004 12:00 AM ET
Dermik Laboratories, the U.S. dermatology arm of the Aventis pharmaceutical company, on Monday applied with the Food and Drug Administration for expedited premarket review of its lipoatrophy treatment Sculptra, currently available in Europe, South America, and Australia as New-Fill. The treatment is an injectable synthetic material that can help fill spaces left by the loss of fat under the skin, particularly in the face. New-Fill has been used by an estimated 100,000 people in 30 countries for the treatment of a range of facial problems, including wrinkles, folds, and sunken cheeks.
"Facial lipoatrophy is a condition that results in loss of fat in the cheeks, temples, and eye sockets," says Sharon Levy, senior director of scientific and medical affairs for Dermik Laboratories. "The sunken cheeks, hollow eyes, indentations, and wrinkling may make a person appear exhausted and unhealthy. Lipoatrophy can result from antiretroviral therapy in people with HIV and can have a devastating effect on self-image and confidence. The effects can be so severe that patients may even jeopardize their health by discontinuing their antiretroviral treatment."
The objective of the studies submitted to the FDA was to determine whether Sculptra safely and effectively produced significant improvements in appearance and in restoration of lost facial volume in people with HIV. Researchers also evaluated the quality of life as well as anxiety and depression scores of study participants. The data from these studies show that Sculptra is well-tolerated, with adverse effects generally limited to reactions at the site of the injection, company officials report.
Sculptra, a poly-L-lactic acid (PLLA), is synthetically derived from natural components and is a biocompatible substance that degrades to lactic acid, a substance naturally produced in the muscles of the body. PLLA has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used in several sustained-release injectable medications.
Lipoatrophy, part of an overall condition called lipodystrophy, is a common problem for HIV-positive people taking antiretroviral drugs, particularly protease inhibitors. It is most often marked by subdermal fat loss in the face, arms, buttocks, and legs. Fat deposits also can form on the back and shoulders and in the stomach area as part of lipodystrophy. Elevated cholesterol and triglyceride levels are other common lipodystrophy symptoms.