In my preview of the Food and Drug Administration advisory panel reviewing VIVUS'
Yeah, I'd call a 20-2 vote in favor of recommending approval confident enough to convince the FDA to approve the drug that it rejected in late 2010.
Ultimately, the panel said, the advantages of weight loss trumped potential heart issues and the risk of birth defects could be managed with a risk-management plan that included female patients taking a pregnancy test.
A positive vote isn't enough to gain approval; it's only a recommendation, after all. A panel recommended approval of Orexigen Therapeutics'
The difference for VIVUS could be the magnitude of the vote. The risk of the FDA going against the panel goes down substantially with each vote recommending approval.
But VIVUS still has some work to do. There are details to be worked out for the risk-management plan to ensure pregnant women avoid taking the drug and VIVUS' commitment to do a post-marketing trial to check for heart issues. The latter is likely the bigger worry, since heart problems discovered post-marketing is what brought down both Wyeth's Phen-Fen and Abbott Labs'
An approval of Qnexa would generally be good news for Orexigen and Arena Pharmaceuticals