(Reuters) - Vivus Inc said it expects a European regulatory committee to recommend against the approval of its obesity drug Qsiva, based on preliminary feedback.
Shares of the company were down 12 percent to $20.66 in premarket trade. They closed at $23.72 on Thursday on the Nasdaq.
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 said it will either resubmit its 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 launched in the United States recently under the trade name Qsymia after receiving marketing approval in July. The U.S. Food and Drug Administration had in June also approved Arena Pharmaceuticals Inc's Belviq - the first new obesity drug in more than a decade.
Both drugs gained U.S. approval after hitting several regulatory roadblocks due to various safety concerns. Safety issues associated with prior obesity drugs, such as the notorious "fen-phen" diet-drug combo, have raised the bar for all new diet pills.
Europe also has reason to be wary of the drugs. In 2008, Sanofi had to withdraw its drug Acomplia when it was linked to an increased risk of suicide.
About 50 percent of adult Europeans are obese or overweight, the company said in a statement.
(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon, Anthony Kurian)
Source: http://news.yahoo.com/vivus-obesity-drug-may-not-eu-committee-backing-112822131--finance.html
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