Zimulti's central concerns

Although sanofi-aventis Group's Zimulti rimonabant is approved in 37 countries to treat obesity, both FDA and its Endocrinologic and Metabolic Drugs Advisory Committee indicated last week that they are not comfortable approving a compound for non-neurologic or non-psychiatric indications that acts primarily on a target that is ubiquitous in the brain, especially in pathways that are not well characterized. The panel noted that this was particularly the case for a drug that is expected to be widely used off label.

The committee voted 14-0 against approval of Zimulti to control weight. ...