FDA panel votes against Debiopharm's Sanvar

An FDA advisory committee voted unanimously on Tuesday that Debiopharm S.A. (Lausanne, Switzerland) has not demonstrated that the potential benefits outweigh the potential risks of Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension. The Gastrointestinal Drugs Advisory Committee also voted 13-1 that the company had not provided substantial evidence of efficacy. ...