Vivus (NASDAQ:VVUS): Current price $12.36
Vivus announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use has confirmed its October 18th decision to decline the Marketing Authorization Application for Qsiva (phentermine/topiramate ER) designed for the treatment of obesity in the European Union. The firm had requested a re-examination of the opinion, but considering the grounds for this request, CHMP once again refused the marketing authorization on Thursday. In its deliberation over the Qsiva MAA, CHMP said that a pre-approval cardiovascular outcomes trial would be required to establish long-term safety.
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