By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Vivus Inc. (VVUS) filed a marketing application with the European Medicines Agency for its Qnexa weight-loss drug. The EMA's review could result in marketing authorization in all 27 European Union member countries, potentially in late 2011, the company said. The move follows a rejection from the U.S. Food and Drug Administration in October, when the agency asked Vivus to provide evidence that Qnexa didn't increase the risk of major adverse cardiovascular events before the agency would consider whether to approve the drug. The agency didn't request another clinical study, and Vivus has said it has sufficient data to meet the FDA's needs. It projected filing a formal response by year end. Vivus is one of three companies trying to get a new obesity treatment approved. Earlier this month, Orexigen Therapeutics Inc.'s (OREX) Contrave received the positive recommendation of an FDA panel for approval, something the other two didn't obtain. Arena Pharmaceuticals Inc. (ARNA) had its drug, lorcaserin, rejected by the agency in October. Orexigen is developing Contrave with Japan's Takeda Pharmaceutical Co. (TKPYY, 4502.TO). Arena is working with that country's Eisai Co. (ESALY, 4523.TO) on lorcaserin. Qnexa is a combination of stimulant phentermine and antiseizure drug topiramate, sold as Topamax by Johnson & Johnson (JNJ). The two drugs work together to reduce appetite and make the user feel more satisfied. In its application for the E.U., Vivus is seeking approval for the treatment of obesity, including weight loss and maintenance of weight loss, noting that the drug should be used with a low calorie diet. Vivus said the drug could be recommended for obese or overweight patients with weight-related problems such as high blood pressure, type 2 diabetes and elevated cholesterol. -By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
