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Vivus receives CHMP negative opinion on Qsiva

October 19, 2012 1:28 AM UTC

As expected, EMA's CHMP recommended against approval of an MAA for obesity drug Qsiva phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS). Vivus said the committee expressed concerns over the potential cardiovascular and CNS effects associated with long-term use, Qsiva's teratogenic potential and its use by patients for whom the drug is not indicated. Vivus plans to appeal the opinion and request a reexamination. Vivus, which made the announcement after market close, was down $1.24 to $21.06 on Thursday. ...