EU committee rejects Vivus weight-loss drug
MOUNTAIN VIEW, Calif. (AP) — A panel of advisers to the European Union's health agency has again rejected Vivus Inc.'s weight-loss drug for sale in Europe.
Vivus, based in Mountain View, Calif., said Thursday after markets closed that the Committee for Medicinal Products for Human Use confirmed its October decision to decline an application to sell the drug under the name Qsiva. Vivus had asked the committee to reconsider that decision.
The drug was approved by the U.S. Food and Drug Administration 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. Sales of the drug, called Qsymia in the United States, started in September, making it the first long-term prescription weight loss drug to reach the market since 1999.
Vivus said the European committee indicated that the drugmaker would have to perform another study that examines cardiovascular safety before Qsiva could be approved. Vivus President Peter Y. Tam said in a statement the company was disappointed.
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