Vivus Expects Negative Decision on Qsiva from the EMA

By Jake King

Vivus Inc. (NASDAQ:VVUS) announced Friday morning that, based on preliminary communication with European regulators, the company doubts it will receive approval of its Marketing Authorization Application of Qsiva (Qsymia in the U.S.) for the treatment of obesity. The FDA approved the drug in July, and the European Medicines Agency is set to decide on the product’s marketing approval in October. Following a negative vote, VVUS says it will either appeal the decision and request a reexamination, or resubmit the application at a later date. Analysts have been modeling international Qsymia sales into Vivus’ valuation, so expect shares to remain weak today on the negative news. Vivus announced U.S. pricing of Qsymia and officially launched the drug domestically earlier this week, which you can read about here. Shares of VVUS have more than doubled in 2012, but are off by 11% in early trading Friday morning.