On Thursday afternoon after the close of the New York York Stock Exchange, a FDA panel voted 10 to 6 against recommending Vivus'(VVUS
) weight loss drug Qnexa for approval. Apparently there was concern that the data supporting Qnexa wasn't strong enough for a drug that could be used by millions for an indefinite time period.
The FDA does not have to act in accordance with the panel's recommendation, although the agency rarely fails to do so. Chief Executive Leland Wilson said the panel vote is "a recommendation and not a final step in the drug-approval process," and that his company would work with the FDA "to address the labeling and safety questions raised during today's proceedings." A final decision is expected in October.
The data that the company presented to the FDA was based on one year, but a company spokesperson said that two-year data will be available by September, so there is definitely still hope for this drug.
"I don't think that Qnexa is dead, but it has to be heavily discounted [from the stock price] until we hear from the FDA," said Rodman & Renshaw analyst Elemer Piros.
According to Lazard analyst William Tanner, "Should Vivus be required to conduct a new trial to generate additional safety data for its low and mid doses, final approval and launch could be delayed by as much as two years."