It ain't over 'til the fat lady sings. Unfortunately for VIVUS
In a move that slashed the pharmaceutical's shares, Food and Drug Administration advisory committee recommended that the agency not approve Qnexa, by a margin of 10 to 6. Or maybe it was 9 to 7; it depends on which vote you want to take as official. Either way, a majority of committee members thought Qnexa shouldn't be approved. The message from the panel is clear: Safety data is important. Really important.
One of the two components of Qnexa is Johnson & Johnson's
Additional two-year safety data from a clinical trial is expected this quarter; whether it'll be enough to sway the FDA, which has the final say, is unknown at this point.
So where does this leave the other two obesity drugs -- Arena Pharmaceuticals'
Contrave's chances for approval seem slimmer after this vote. The drug, which combines GlaxoSmithKline's
Lorcaserin has fairly mild side effects, and more safety data, but provides a fairly minimal amount of weight loss. The advisory panel was focused on safety this week, but that doesn't mean panel members won't be focused on efficacy when they review lorcaserin in September. The high risk of not getting approved is the very reason I thought the company should have taken more up-front cash from Eisai.
In my article earlier this week, I warned that there are no easy layups from here. Half-court shots are even harder.