FDA Approves Drug for AIDS Wasting
FDA has approved Serostim (somatotropin) to treat AIDS wasting syndrome in HIV-infected patients. AIDS wasting is a metabolic disorder characterized by weight loss. The following may be used to respond to questions.
Severe loss of weight and muscle, or lean body mass, common among AIDS patients, leads to muscle weakness, organ failure, and contributes to fatal outcomes. Results from one clinical trial of Serostim, a human growth hormone (HGH), showed that the drug increased the lean body mass of HGH-treated patients by an average of 1.6 kg (3.5 lbs.) Compared with placebo-treated patients.
The most common adverse effects associated with the treatment included tissue swelling, as well as muscle and joint pain.
Serostim was granted an accelerated approval -- a regulatory mechanism under which the agency may grant early approval of a drug used to treat patients with serious or life-threatening illnesses, and that provides meaningful therapeutic benefit over existing therapies.
Accelerated approvals are based on surrogate endpoints in clinical trials, rather than on clinical outcomes such as strength or longer survival. Under the terms of this accelerated approval, the firm has agreed to conduct additional clinical studies to evaluate whether there is improvement in physical performance, and to substantiate previous findings of increased lean body mass.
More than 300 patients have already been treated wit Serostim since December 1994 under a treatment IND that allows pre-market access to the drug.
Serostim is administered by injection. It will be distributed by Serono Laboratories, Inc., of Randolph, Mass.
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest, Talk Papers are subject to change as more information becomes available. Talk Papers are not intended for general distribution outside FDA, but all information in them is public, and full texts are releasable upon request.
Food and Drug Administration U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, Maryland 20857