HIV patients who suffer from a disease called facial wasting will be able to treat sunken cheeks, hollow eyes and other signs of the virus with a new drug approved by the U.S. government on Tuesday.
HIV patients who suffer from a disease called facial wasting will be able to treat sunken cheeks, hollow eyes and other signs of the virus with a new drug approved by the U.S. government on Tuesday. The Food and Drug Administration (FDA) okayed the injectable drug, Aventis’ Sculptra, to plump deep wrinkles and pockets that can stem from antiretroviral drugs used to treat the AIDS-causing illness. While not a physical danger, the disease, called lipoatrophy, can lead to depression and other emotional problems. “Change in facial appearance is one of the emotionally devastating and stigmatizing side effects of HIV/AIDS and the drugs used to treat it,” said FDA Acting Commissioner Lester Crawford. Made from the same type of material used in dissolvable stitches, Sculptra is used to fill areas of the body affected by fat loss. Aventis subsidiary Dermik Laboratories makes the drug, which is already marketed in Europe as a wrinkle-filler under the name New-Fill and is used in more than 30 countries. The company said Sculptra will be available in the United States during the third quarter of this year. The French drug maker has said it plans to start cosmetic trials this year and will eventually seek U.S. approval for Sculptra as a wrinkle treatment. Sculptra could be a blockbuster drug in the United States with more than $1 billion in potential annual sales, the company has said. An FDA advisory panel earlier this year expressed concern that U.S. doctors might use Sculptra as wrinkle treatment for people without AIDS. Once a drug is approved, doctors are free to prescribe it for other “off-label” uses. About half of all HIV-positive people will eventually develop lipoatrophy, the FDA said. It estimated 900,000 to a million Americans have been diagnosed with HIV.As a condition for Tuesday’s approval, Dermik will conduct additional studies to monitor long-term safety, particularly in women and patients with darker skin, the FDA said. Most patients previously studied were white male HIV patients in their early forties. Common side effects shown in those studies included nodules, redness and other irritation at the injection site. The approval comes days after the company’s rival Sanofi-Synthelabo closed its takeover offer that would create the world’s third largest drugmaker. Results of the offer, which is worth $62.7 billion (52 billion euros), are expected by August 12. Shares of Aventis edged up 10 cents to $79 on the New York Stock Exchange late Tuesday afternoon. (Source: Reuters, August 2004)