Sculptra

Treatment for Facial Lipoatrophy; Facial Wrinkles

Update: Sculptra Now FDA Approved - August 3, 2004

Sculptra From Dermik Laboratories Receives Recommendation For Approval With Conditions From FDA Advisory Panel

STRASBOURG, France, March 26, 2004 -- Dermik Laboratories, the U.S. dermatology arm of Aventis, announced today that a U.S. Food and Drug Administration (FDA) advisory committee has unanimously recommended, with conditions, U.S. marketing approval of Sculptra (injectable poly-L-lactic acid) for the proposed indication to correct shape and contour deficiencies resulting from facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

"Dermik is pleased with the panel’s recommendation," said Robert Bitterman, President of Dermik. "Many people with human immunodeficiency virus desperately need a safe and effective treatment for facial lipoatrophy. By granting the product an expedited review, the FDA recognized that Sculptra satisfies an unmet medical need, and Dermik will work with the Agency to bring Sculptra to market as rapidly as possible."

Facial lipoatrophy is the loss of fat that supports the fullness, shape and contour of the face. Clinical trials with Sculptra, in people with lipoatrophy associated with human immunodeficiency virus, demonstrated noticeable results that typically lasted for up to two years after the first session. Adverse effects were generally limited to the site of the injection and included temporary redness and swelling and small, typically non-visible bumps.

"The physical signs of lipoatrophy resulting from HIV infection and its associated anti-retroviral therapy can be so distressing that people may discontinue life-preserving treatment. The FDA panel’s recommendation is a critical first step toward bringing a safe and effective treatment for facial fat loss to people with HIV," said Marcus Conant, MD, clinical professor, UCSF Medical Center. "Sculptra would give those patients an important treatment for long-lasting correction of facial shape and contour deficiencies."

The panel recommended approval of the product with conditions: a post-approval study, a physician training program, product use limited to people with human immunodeficiency virus who have lipoatrophy, provision of product specification information, and wording changes to the proposed label.

Sculptra is marketed outside of the United States under the trade name NEW-FILL. The French Notified Body G-Med (Department of Evaluation of Medical Devices) approved the product in 1999 as a wrinkle filler and in 2004 for large volume corrections of the signs of lipoatrophy. The product has been used by an estimated 150,000 people in more than 30 countries in Europe, South America, and Australia to treat a variety of facial volume and contour deficiencies, including signs of aging such as wrinkles, folds and sunken cheeks.

Because poly-L-lactic acid is a polymer synthetically derived from natural components and is a biocompatible substance, there is no need to test for allergic reactions. It has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used as a vehicle for several sustained release injectable medications.

About Dermik Laboratories
Dermik Laboratories conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis. Dermik is dedicated to providing innovative dermatological products to satisfy the needs of health care providers and patients. Dermik continues its strong commitment to innovative treatments for skin and nail conditions, including acne, nail fungus, pre-cancerous skin lesions, psoriasis and rosacea. It is headquartered in Berwyn, Pennsylvania.

Posted: March 2004

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