Serono Laboratories Inc. regulatory update

The FDA granted accelerated approval to Serono's Serostim (somatropin human growth hormone for injection) to treat cachexia (wasting) in AIDS. Serostim acts as an anabolic and anticatabolic agent. The drug provided statistically significant increases in lean body mass and decreases in body fat in one of the company's 12-week trials, but not in the other.

In the first trial, patients received 0.1 mg/kg/day of Serostim subcutaneously versus placebo. In 140 evaluable patients, the mean difference in the Serostim-treated group was 1.6 kg (3.5 lb). After 12 weeks, 74 percent of treated patients gained weight versus 48 percent of the placebo group (p=0.002). ...