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Vivus says obesity drug may fail EU test, shares fall

(Reuters) – Vivus Inc said it expects a European committee to recommend against the approval of its obesity drug Qsiva, based on preliminary feedback from the committee.

The formal decision from the European Medicines Agency‘s Committee for Medicinal Products for Human Use is expected following their October meeting.

If a negative recommendation is issued in October and depending upon issues raised, Vivus will either resubmit the marketing application at a later date or appeal the decision and request a re-examination.

“We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe,” Vivus President Peter Tam said in a statement.

Qsiva was approved by the U.S. health regulators in July and was recently launched in the United States under the trade name Qsymia.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)