A panel of advisers to the European Union’s health agency has again rejected Vivus’ weight-loss drug for sale in Europe.
Vivus, based in Mountain View, 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.
“We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favorable safety and efficacy profile of Qsiva,” he said, noting that a committee scientific advisory group gave the drug a positive recommendation.
Qsymia is the company’s only marketed product. U.S. sales of the drug started slowly, something Vivus has attributed in part to high out-of-pocket costs for patients and limited insurance coverage.
But the company said in January that prescriptions for the weight loss pill surged in late November and December. Analysts say annual sales of Qsymia will eventually top $1 billion.
Vivus shares finished at $12.88 on Thursday. Its shares have rebounded from a 52-week low of $9.86 in mid-November. They are almost 60 percent below their high of $31.21 in mid-July.