MOUNTAIN VIEW, Calif. (AP) – Vivus Inc. said it asked European regulators to approve its weight-loss drug Qnexa, which has already been rejected by U.S. regulators because of concerns over links to potential heart problems and birth defects.
The company has already submitted a briefing document to the Food and Drug Administration to address the agency’s concerns and plans on meeting with the FDA in January.
In Europe, the European Medicines Agency will review the company’s application.
Despite the FDA’s initial rejection of Qnexa and potential competitor Arena Pharmaceuticals Inc.’s lorcaserin, Wall Street has been more positive on the drugs’ prospects as resubmissions. On Dec. 7, an FDA panel of experts recommended that the agency approve Orexigen Therapeutics Inc.’s weight loss drug Contrave, making it the first in group of competitors to get a positive nod from experts. The FDA is not required to follow the advice of its expert panels, but often does.
The agency is scheduled to make a decision on Contrave by Jan. 31.
Date: December 20, 2010
Source: Associated Press