Drug company Vivus’s share price has plummeted after an FDA advisory committee stated the obesity treatment it is developing should not be approved.
According to media reports, the committee voted 10-6 against weight loss treatment Qnexa, which is trying to gain approval in a very tricky area (see yesterday’s blog: Diet pill passes clinical trial test).
Although the drug has been shown to help with weight loss, it has also been linked to suicidal thoughts, heart problems and birth defects. "Some of these side effects are serious and could be life-threatening and must be weighed against a relatively modest weight loss,” says panel chair, Kenneth Burman (AP).
Pharmatimes reports:
The panel were particularly concerned that the data presented by Vivus is not long-term enough (ie just over 12 months) and potential patients would be taking the combo for life. … The rejection, though narrow, came as a bit of a surprise, and Eric Colman, deputy director of FDA’s deputy director of the FDA’s metabolic and endocrinology products division, said at a press conference that “when you listen to even the ‘no’ votes, you got the sense that a lot of people, they weren’t strongly against the drug but had lingering concerns”.