) --Via Twitter, @trokalayjian tweets,
"@adamfeuerstein didn't you write that the FDA was going to ask for outcomes study $vvus - :)"
I did and I still believe that to be true.
(VVUS - Get Report)
shares rose Thursday after the company announced plans for an "early resubmission" of its obesity drug Qnexa to the Food and Drug Adminstration. The new approval filing will limit Qnexa use to men and women of "non-child bearing potential."
The FDA rejected Qnexa last year citing concerns about the potential for birth defects related to the topirimate component of Qnexa. Vivus has been conducting a study to examine the birth defect issue with results expected in December.
Instead of waiting for those birth defect safety data, however, Vivus will resubmit Qnexa for approval in October, which sets up a second approval decision in April 2012. FDA will hold a second advisory panel to review Qnexa in the first quarter, Vivus said. The first Qnexa panel, held last year, voted against the weight-loss drug.
After witnessing the way FDA dealt harshly and skeptically with all three obesity drugs (
Contrave), I find it exceedingly difficult to have any confidence in a better outcome for Vivus' second shot at a Qnexa approval.
The FDA has made it clear that it's very concerned about the cardiovascular safety of all obesity drugs, and Qnexa, in its clinical trials, demonstrated a small but numerically higher incidence of heart attacks compared with placebo. [The drug also causes an elevated heart rate.]
Just because the FDA hasn't yet asked Vivus for additional heart safety data or told the company to run a cardiovascular outcomes study does not mean regulators won't come back and ask for those data in the future. In fact, I expect the FDA is gearing up to raise the heart-safety bar on all current and future obesity drugs, Qnexa included.
As for the "early resubmission" of Qnexa, well, that's just PR spin. Vivus long ago said it planned to refile Qnexa in the fourth quarter. After starting the birth defect safety trial, the company walked back that guidance, saying it expected to have results from the birth defect trial in the fourth quarter, which would then be followed by a refilling.