Aventis' Sculptra has become the first drug to receive FDA approval for the treatment of facial fat loss (lipoatrophy) in HIV/AIDS patients.

It is estimated that one million people in the US are HIV-positive and 50% will develop lipoatrophy, with about 150,000 to 350,000 patients potentially benefiting from the French drug maker's new treatment.

The FDA said it had expedited review of Sculptra, an injectable filler, because of its importance to people with HIV/AIDS. It is thought the condition ­ which includes facial wasting, sunken cheeks, eyes and temples - is caused by antiretroviral drug therapy.

"Change in facial appearance is one of the emotionally devastating and stigmatising side-effects of HIV/AIDS and the drugs used to treat it," said FDA acting commissioner Dr Lester M. Crawford. "The AIDS community has been awaiting a product like this that can give patients a smoother, fuller face."

"We are very pleased that the FDA has recognized the need for Sculptra with its expedited review and approval," said John Leone, president of Aventis Dermatology, a global unit of Aventis. "Now, people with human immunodeficiency virus who suffer from the effects of facial lipoatrophy will have a safe and effective FDA-approved treatment."

Sculptra is a polymer used to create dissolvable stitches ­ under the brand name New-Fill it has been used in injectable form as a wrinkle filler in Europe since 1999 and for large-volume corrections of lipoatrophy since 2004.

The FDA's US approval was based on clinical studies submitted by Sculptra's manufacturer and marketer Dermik Laboratories ­ Aventis' US dermatology arm.

The study of 278 HIV-positive patients, taking antiretroviral drugs, showed the treatment improved facial shape and appearance, with the results, in most cases, lasting two years, although the FDA cautioned repeat treatments were necessary if the substance broke down.  

"For years, people have tried a variety of procedures to correct sunken cheeks, hollow eyes, indentations, and other signs of facial fat loss - a common side-effect of antiretroviral therapy for human immunodeficiency virus. Until now, there have been no treatments approved by the FDA specifically for this condition," said Dr Marcus Conant, clinical professor, UCSF Medical Center. "Sculptra is a well-tolerated, breakthrough treatment that can be administered during an outpatient office visit and offers long-lasting results."

As a condition of approval, the FDA has told Dermik to monitor 100 patients for five years - including at least 30 females and 30 people with dark skin types (previous studies had featured mostly white men) - to evaluate Sculptra long-term safety.

pharmafocus@pharmafile.co.uk