MOUNTAIN VIEW, Calif., Sept. 20, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced it has submitted to the European Medicines Agency (EMA) a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial (CVOT) to support the resubmission of the marketing authorization application (MAA) for approval in Europe of Qsiva™ for obesity under the centralized procedure. In order to accommodate advice from the European authorities, VIVUS anticipates that patient enrollment for the AQCLAIM study will commence in first quarter 2014.
VIVUS Updates European Filing Strategy For Qsiva
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