FDA gives full approval to Serostim
BY Advocate.com Editors
September 04 2003 12:00 AM ET
The Food and Drug Administration on Friday gave full approval for the marketing of Serostim for the treatment of HIV-related wasting. The compound received accelerated approval in 1996, a special regulatory status granted by the FDA for a drug used to treat patients with life-threatening illnesses. The full approval was based on a multi-center, placebo-controlled study of 757 HIV-positive people showing that the injectable medication is effective in increasing lean muscle mass and boosting weight in patients suffering from AIDS-related wasting.
"We are very pleased that the FDA has granted full approval for Serostim," said James Sapirstein, executive vice president at Serono, the maker of the drug. "Wasting continues to be a major concern in the management of HIV and AIDS treatment, even with the benefits of highly active antiretroviral therapy. Serostim makes an important and positive difference in the physical endurance of people experiencing HIV wasting."
Serostim is the only growth hormone approved by the FDA for the treatment of AIDS-related wasting. The drug is not available in Europe; in April 2003, the European Medicines Evaluation Agency rejected Serono's application to market the medication. About 6,000 HIV-positive people in the United States are prescribed Serostim. A 12-week course of the drug costs about $21,000.