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Tuesday, June 5, 2012

VIVUS Provides Update on Timing of European Decision for Qnexa


VIVUS, Inc. VVUS -2.49% today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rescheduled the decision process on the Marketing Authorization Application (MAA) for Qnexa, an investigational drug for the treatment of obesity. In April, VIVUS submitted its response to the Day 180 List of Outstanding Issues from the CHMP, and was invited by the CHMP to participate in an oral hearing in order to provide additional explanations of the Day 180 response. An oral hearing is a customary part of the EMA approval process. VIVUS requested additional time to prepare for the oral hearing, and the CHMP has agreed to schedule the hearing in September 2012. The CHMP opinion on the Qnexa MAA is now expected following the September meeting.

"We appreciate the flexibility of the CHMP to work with us on the timing of the oral hearing and the scheduling in September," said Peter Tam, president of VIVUS. "We look forward to presenting to the CHMP in September, but are currently focused on working with the FDA ahead of the July 17, 2012 PDUFA and the potential Qnexa launch in the U.S. in the second half of this year."

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