MOUNTAIN VIEW, Calif. (AP) -- Vivus Inc. said Friday it believes a panel of advisers to the European Union's health agency will recommend against approving its weight loss drug Qsymia.
Vivus said its opinion is based on "preliminary feedback" from the Committee for Medicinal Products for Human Use. The panel is expected to make a recommendation in October. After that the European Medicines Agency will make a ruling on the marketing of Qsymia.
If the drug is not approved, Vivus said it will file a new marketing application or appeal the agency's decision. Vivus wants to market the drug in Europe under the name Qsiva. The received U.S. approval in July and it is Vivus' only marketed product.
Shares of Vivus fell $2.77, or 11.7 percent, to $20.95 in morning trading, but for the year to date, shares have more than doubled.
Vivus announced Monday that Qsymia is now available in the U.S., making it the first long-term prescription weight loss drug to reach the market since 1999. The Food and Drug Administration approved the drug in July for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
The FDA also approved Arena Pharmaceuticals Inc.'s drug Belviq in June, and Belviq is expected to go on sale in early 2013. Qsymia is generally seen as the more effective of the two drugs.
- European Medicines Agency