FDA panel supports approval of Orexigen's obesity drug

In what is likely to prove a shocker for many FDA watchers, the agency's expert advisors voted 13 to 7 in favor of approving Orexigen's obesity drug Contrave.

In what is likely to prove a shocker for many FDA watchers, the agency's expert advisors voted 13 to 7 in favor of approving Orexigen's ($OREX) obesity drug Contrave. After two negative votes for the weight drugs advanced by Arena ($ARNA) and Vivus ($VVUS), the surprising Orexigen decision followed an 11 to 9 vote in favor of requiring a study of cardiovascular safety issues post-approval rather than before the drug hits the market. If that closer CV study vote had gone against Orexigen, Contrave would have been significantly delayed.

As it stands now, Orexigen  suddenly leaps into the lead among the biotech players angling for an FDA approval, which would open the door to a potential $1.2 billion in peak annual sales. Among the reporters covering the FDA session today, several noted that the panelists had not been overwhelmed by the efficacy data available for Contrave. But several of the panel members didn't want to move the goal posts for a developer this late in the