Serono Laboratories Inc. regulatory update

In a joint action, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Antiviral Drugs Advisory Committee voted 8-7 against approving the company's NDA for Serostim human growth hormone for the treatment of wasting in AIDS.

According to the company, the FDA was concerned that the second Phase III trial looked only at overall weight gain, and did not distinguish between lean body mass and fat. The first Phase III trial, begun three years ago, measured total body weight as the clinical end point, and also examined body composition. ...