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发帖数: 462 | 1 A lot of options will be dead
http://www.businessweek.com/news/2012-04-09/vivus-weight-loss-d
Vivus Inc. (VVUS) (VVUS) said U.S. regulators delayed their decision date on
whether to approve the obesity pill Qnexa by three months to July 17.
The date was extended after Vivus submitted, at the Food and Drug
Administration’s request, a risk evaluation and mitigation strategy, the
company said today in a statement. The strategy is based on discussions with
the agency after advisers voted Feb. 22 in favor of the medication, while
raising concern that the drug may potentially contribute to heart risks and
birth defects.
The extension is standard to provide time for a full review, Vivus said. The
Mountain View, California-based company is competing with Arena
Pharmaceuticals Inc. (ARNA) (ARNA) and Orexigen Therapeutics Inc. (OREX) (
OREX) to bring the first weight-loss drug to market in 13 years.
“The Qnexa REMS submission is comprehensive, with materials based on
ongoing feedback from the FDA since our advisory committee meeting in
February,” Leland Wilson, chief executive officer of Vivus, said in the
statement. “We look forward to finalizing our REMS with the FDA while we
move forward with our commercialization plans.”
Vivus declined (VVUS) 8.2 percent to $21.03 in extended trading at 7:31 p.m.
New York time after gaining 1.7 percent to $22.92 at the close.
Qnexa raised patients’ heart rates in clinical trials. The pill is a
combination of the appetite suppressant phentermine and topiramate, an
antiseizure and migraine drug.
The company submitted its risk mitigation plan on April 4, Vivus said in its
statement. |
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