Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - November 16, 1995
The policy of "fast track" designation gives all AIDS drugs top priority for review within the FDA. The system was implemented in order to expedite the review of drugs and exemplifies the FDA's effort to produce more timely and efficient reviews for all breakthrough drugs.
"AIDS wasting is a major contributor to morbidity and mortality in patients with HIV infection," said Hisham Samra, MD, president, Serono Laboratories, Inc. "We are extremely pleased by the promising clinical reports for Serostim in AIDS wasting patients. We are hopeful this drug will prove to be an important new therapy for those afflicted with this condition."
On September 11, Serono submitted to the FDA a New Drug Application (NDA) which included Phase I, II and III data to support the safety and efficacy of Serostim in adults with AIDS wasting, a metabolic alteration or derangement often referred to as catabolism or cachexia. Serono's NDA application also included the results and analyses from two Phase III placebo-controlled, double-blind studies and an additional open- label continuation study.
The initial pivotal trial was a 12-week, randomized double-blind, placebo-controlled study of 178 subjects, 172 male and 6 female, with a mean age of 39. Data from this study were presented by Morris Schambelan, M.D., San Francisco General Hospital, at the Third International Symposium on Nutrition and HIV/AIDS held in October 1994. This data showed that those patients taking Serostim gained an average of 6.6 pounds of lean body tissue, while losing an average of three pounds of fat. Also, patients who gained lean body mass improved their strength and endurance as measured by their performance on treadmill tests and showed significant improvements in quality of life, as measured by the HIV Parse survey.
AIDS Wasting
The U.S. Centers for Disease Control (CDC) has defined AIDS wasting as a loss of ten percent or more of a person's ideal body weight. AIDS wasting is one of the primary indicators of progression from HIV infection to symptomatic HIV disease and is a leading cause of death among people with AIDS. Recent literature indicated that true AIDS wasting is a metabolic disorder that causes the body to inappropriately burn muscle and organ tissue (lean body mass) instead of fat.
Serono Laboratories, Inc., a pharmaceutical company based in Norwell, MA, is the United States member of The Ares-Serono Group, based in Geneva, Switzerland. Ares-Serono and Serono Laboratories are focused on the development, production and marketing of products in the areas of growth and metabolism, reproductive health and immunology/oncology.
CONTACT: Gina M. Cella of Serono Laboratories, 617-982-9000/ 09:43 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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