Shares of Vivus ($VVUS) spiked more than 14% this morning after the FDA agreed to clear a potential roadblock for its obesity drug Qnexa. The Mountain View, CA-based biotech announced early today that the agency signaled its willingness to strip a contraindication for the weight drug for all women of childbearing age in its resubmitted NDA, content to keep the proscription for pregnant women.
"The company's disclosure of this regulatory update should not be interpreted to mean that the potential for FDA approval of Qnexa has improved or that, if approved, that the final Qnexa label would not include contraindications or warnings for specific populations, including women of childbearing potential," cautioned Vivus President Peter Tam. But investors interpreted the move as a distinct positive for Vivus, which has been pushing hard to become the first drug developer to gain an approval for a weight drug in more than a decade.
As investors reponded to the prospect of a bigger market, though, some analysts fretted over the prospect that last-minute regulatory changes can only extend the time it will take the FDA to make up its mind on marketing. "They're changing things in mid-process," Leerink Swann's Steve Yoo tells Bloomberg. "Anytime you change things in mid-process, the timelines can be pushed out."
Vivus scored a win last fall when it struck a deal with regulators for an early resubmission of Qnexa, which included the contraindication for women of childbearing age. An expert panel will meet in February and a final decision is due by April 17.
- here's the Vivus release
- here's the Bloomberg report