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Obesity: REMS, stopping rules, teratogenicity data win FDA panel vote on Qnexa
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Vivus: Back for seconds
Monday, February 27, 2012
A beefed up REMS and clearer picture of the safety profile for
obesity candidate Qnexa phentermine/topiramate allowed Vivus
Inc. to score a positive vote at last week's FDA advisory panel
meeting, but the other two obesity candidates turned down by the agency can't
count on finding the same success the second time around.
The reason: While all three
candidates have safety signals that are difficult to exclude without large and
lengthy trials, only Qnexa's efficacy has never been in doubt.
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