Berwyn, PA -- Dermik Laboratories, the U.S. dermatology arm of Aventis (another pharmaceutical company), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted expedited review of the company's Premarket Approval Application (PMA) for SculptraTM (injectable poly-L-lactic acid), a long-lasting, synthetically derived, dermal contouring agent to help restore lost facial volume in people with lipoatrophy. Facial lipoatrophy can be characterized by loss in fullness, shape and contour of the face.
SculptraTM is marketed under the trade name NEW-FILL® in Europe, where it was approved by the Department of Evaluation of Medical Devices in 1999 as a wrinkles filling product. SculptraTM has been used by an estimated 100,000 people in more than 30 countries throughout Europe and South America, and in Australia, for the treatment of a range of facial imperfections, including signs of aging, such as wrinkles, folds and sunken cheeks.
"Facial lipoatrophy is a condition that results in loss of fat in the cheeks, temples and eye sockets. The sunken cheeks, hollow eyes, indentations and wrinkling may make a person appear exhausted and unhealthy," said Dr. Sharon Levy, senior director of Scientific & Medical Affairs for Dermik Laboratories. "Lipoatrophy can result from the use of anti-retroviral 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 anti-retroviral treatment."
The objective of the studies submitted to the FDA was to determine whether SculptraTM 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 and anxiety and depression scores of study participants. The data from these studies are intended to show that SculptraTM is well-tolerated, with adverse effects generally limited to reactions at the site of the injection.
"There is a significant unmet need in the United States for an FDA-approved lipoatrophy treatment that is safe, effective and long-lasting," said Robert J. Bitterman, president of Dermik Laboratories. "We are committed to working with the FDA to provide those who experience the symptoms of facial lipoatrophy with a treatment that can help improve their physical appearance and overall well-being."
Poly-L-lactic acid (PLLA) is synthetically derived from natural components and is a biocompatible substance that degrades to lactic acid. PLLA has been used in surgical products for more than 20 years as a component of dissolvable VicrylTM sutures and is used as a vehicle for several sustained release injectable medications.
According to John Leone, president of Aventis Dermatology, "The submission of the SculptraTM PMA to the FDA represents a major milestone for our newly created global Aventis Dermatology division. The market and need for aesthetic dermatology is growing rapidly and SculptraTM represents a significant advance for those individuals with signs of facial lipoatrophy."
Note: "Filing" with the FDA doesn't mean that the medication or product has been approved for use. It is simply a process to which all medications and products have to go through before reaching the US market.