By the close of business on Friday, the mixed review Orexigen's ($OREX) obesity drug Contrave earned at the FDA had inspired more fear of the risks involved than the potential efficacy of the treatment, with shares sliding 12 percent over the course of the day. Signs of elevated blood pressure in patients appeared to be a key panic button--especially as the experts on the FDA advisory panel has already made it crystal clear that any kind of cardio risks are not being tolerated.
"It's quite clear that the safety discussion will once again be key, especially with regard to cardiovascular risk where Contrave may face an uphill battle," J.P. Morgan analysts An approval, though, is likely to open up a blockbuster market for Orexigen, so there will be plenty of attention as the agency's experts put Contrave under the microscope tomorrow.
The FDA panel has already turned thumbs down on both Vivus and Arena. And as Contrave managed to hit only one of two key regulatory standards on efficacy, the betting is likely to be fast and furious as the panel weighs in Tuesday. The panel's key question may well be whether a dedicated cardio study should be conducted before or after approval.
- here's the Reuters story