FDA approves SculptraAesthetic

July 29, 2009

Bridgewater, N.J. - Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved SculptraAesthetic (injectable poly-L-lactic acid) for the correction of shallow-to-deep nasolabial fold lines, contour deficiencies and other facial wrinkles, which are treated with the appropriate injection technique in healthy patients. SculptraAesthetic works gradually to offer natural-looking results that can last up to two years, the company says.

Bridgewater, N.J. - Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved SculptraAesthetic (injectable poly-L-lactic acid) for the correction of shallow-to-deep nasolabial fold lines, contour deficiencies and other facial wrinkles, which are treated with the appropriate injection technique in healthy patients. SculptraAesthetic works gradually to offer natural-looking results that can last up to two years, the company says.

"We are excited by the FDA approval of SculptraAesthetic, because it changes the landscape of what physicians can offer patients seeking natural and gradual looking results from an aesthetic injectable that is long-lasting," said Doris Day, M.D., Clinical Assistant Professor of Dermatology, New York University, and in private practice in New York City. "SculptraAesthetic allows for a natural correction."

The FDA approval of SculptraAesthetic is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. Patients received SculptraAesthetic or an approved human derived collagen for the treatment of their nasolabial-fold wrinkles.

SculptraAesthetic was administered in a single treatment regimen, at three-week intervals, for up to four treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique. The SculptraAesthetic patients were followed for an additional 12 months. SculptraAesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to three months.

"SculptraAesthetic showed effective correction of the nasolabial folds, which are considered to be the hallmark signs of facial aging," said Paul Chew, M.D., Chief Science Officer/Chief Medical Officer, Sanofi-aventis U.S.

No serious adverse events were reported in this study for either treatment. Commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling and were reported in both treatment groups. Other adverse events reported during the 25-month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own; one small lump required treatment by the healthcare provider.