Vivus Inc. (VVUS)’s obesity drug, approved in July in the U.S., failed for a second time to gain the backing of European regulators because of its potential side effects.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended against approving Vivus’s pill in October because of concern about the long-term effects on the heart and nervous system. Vivus appealed, and the Mountain View, California-based company said today in a statement that its request was rejected.
The agency, called CHMP, said Vivus must conduct a cardiovascular trial to show the drug, which would be called Qsiva in Europe, is safe before it could be approved.
“We are disappointed with the CHMP decision regarding Qsiva and the position the committee adopted with respect to the need for a pre-approval cardiovascular outcomes trial,” Peter Tam, president of Vivus, said in the statement. “A majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery.”
The drug, called Qsymia in the U.S., was the second weight- loss drug to be cleared last year by the Food and Drug Administration. The therapy is a combination of the appetite suppressant phentermine and the anti-seizure drug topiramate.
Vivus declined 1.9 percent to $12.88 in trading today before the statement was released. The shares have gained 22 percent in the past 12 months.
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