) -- It was a tough day for
(VVUS - Get Report)
Thursday after an outside panel of experts convened by the U.S. Food and Drug Administration narrowly rejected the company's weight-loss drug Qnexa on concerns about the drug's long-term safety.
The initial advisory panel vote was 9-7 against Qnexa, then 10-6 when one "yes" panelist reversed his vote. During the discussion period following the vote, one of the "no" experts said he could have voted for approval, so however you look at it, the decision was a close one.
If approved, Qnexa would have been the first, new weight loss drug to reach the market in a decade, and with 1 in every 3 Americans overweight or obese, the drug might have been used by millions of people. That put the
drug's safety at the forefront of the discussion Thursday
. Vivus' approval application included one year's worth of safety data but that was not sufficient enough to satisfy panel members, who cited the potential for cardiovascular and pregnancy/birth defect risks as their top concerns.
Despite the negative vote Thursday, Vivus and Qnexa are not dead. Delayed, yes, but I still believe Qnexa can be approved. Some additional thoughts and comments:
For the sake of accountability, let me say near the top that
my prediction of a positive Qnexa panel vote was wrong
. I rightly recognized that the Qnexa decision was going to come down to a referendum on the drug's safety, and I said the vote would be close, but I failed to recognize or appreciate how much the lack of long-term safety data would have on the decision. That was a big mistake on my part.
A top FDA official seemed sympathetic to Qnexa in post-panel comments Thursday, expressing surprise over the negative vote. Interesting, but I don't think that helps Vivus gain approval for the drug by the agency's Oct. 28 approval decision date. The FDA has been known to go against panel recommendations before, but that's not going to happen in this case, so a significant delay is all but certain.
Vivus is collecting two-year safety data on Qnexa, which the company said would be ready later this quarter. Clearly, Vivus is going to submit the new safety data to FDA as soon as possible. At best, FDA will take six months to review the new safety data, but conservatively, it's probably a year delay for Qnexa's approval -- the fourth quarter of 2011, perhaps into early 2012.