BioCentury
ARTICLE | Regulation

The market moved

May 25, 2009 7:00 AM UTC

Based on the outcome of its FDA advisory committee meeting last week, Debiovision Inc.'s effort to get agency approval for Sanvar vapreotide is likely to fail because of two advances in medical practice. One made it unfeasible to conduct placebo-controlled trials of Sanvar. The other diminished the need for the agent to reduce blood flow in conjunction with surgery to stop varices, or dilated veins, from bleeding.

The Gastrointestinal Drugs Advisory Committee voted unanimously that available data do not indicate that the potential benefits of Sanvar outweigh the potential risks for control of acute variceal bleeding...