Wrinkle filler faces FDA panel review

An injectable treatment to fill deep wrinkles and help pad sunken cheeks could soon boost the confidence of HIV patients -- and aging baby boomers.

Dermik Laboratories is seeking the first approved treatment for so-called face-wasting disease in HIV patients, but some medical experts say Sculptra will become a general wrinkle treatment.

The compound faces review on Thursday by a U.S. Food and Drug Administration expert panel that will weigh whether or not to recommend final approval. The FDA usually follows the advice of its panels.

A 'blockbuster drug'?
The synthetic polymer is already marketed in Europe as a wrinkle-filler under the name New-Fill and is used in more than 30 countries, according to French drugmaker Aventis, which owns Dermik.

Antiretroviral drugs used to treat the virus that causes AIDS can also lead to fat loss in the face, giving it a sunken appearance.

But Dr. Stephen Mandy, a dermatology professor at the University of Miami not involved with Sculptra trials, said he expected it would be used most for people without AIDS who simply want a younger look.

“The number of AIDS patients is nothing compared with the number of baby boomers who are going to need their wrinkles filled,” said Mandy.

Once a drug is approved, doctors are free to prescribe it “off-label” for other uses.

Aventis has said it expects to launch Sculptra in the United States later this year with more than $1 billion in potential annual sales.

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“At its peak, we believe it will be a blockbuster drug,” Aventis spokeswoman Patricia Munzer said.

Cosmetic trials planned
Another Aventis source, who spoke on condition of anonymity, said the company planned to start cosmetic trials in the second half of 2004 and would eventually seek U.S. approval as a wrinkle treatment.

Dermik officials declined to comment.

Short-term risks include bleeding or tenderness from the injection as well as possible bruising. Over time, hard nodules can also form.

While Sculptra faces competition from a crowded field of collagen and other injectable wrinkle treatments, advocates for AIDS patients say the need to treat face wasting is far from cosmetic.

“That’s the terrible irony of this side effect. It makes them look sick, but they’re not,” said Gretchen Schmelz Armstrong of American Foundation for AIDS Research.