In Brief: Serono Labs' Serostim for AIDS wasting
Executive Summary
Serono Labs' Serostim for AIDS wasting: NDA submitted Sept. 11 for the mammalian cell-derived recombinant human growth hormone. Results and analysis of two Phase III trials and an open-label continuation study were included in the NDA. Patients receiving Serostim gained lean body mass while losing fat and performed better on treadmill endurance tests than placebo patients, and "there is sufficient data in the NDA showing Serostim impacts a number of immunological parameters," Serono said. Serostim has been available under a Treatment IND since December 1994; a total of over 500 patients have been treated through study protocols or expanded access...