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Vivus Inc. (VVUS)’s obesity drug, approved in July in the U.S., failed to gain the backing of European drug 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, to be marketed under the name Qsiva in Europe, because of concerns about negative cardiovascular and nervous system effects from long-term use, the Mountain View, California-based company said yesterday in a statement. Vivus plans to appeal the decision.
“The lack of effective pharmacologic treatments for obesity remains a high medical need for many patients in Europe,” Peter Tam, Vivus’s president, said in the statement. “We are committed to getting Qsiva approved in Europe.”
The drug, called Qsymia in the U.S., was the second weight- loss drug to be cleared this year by the Food and Drug Administration. The therapy is a combination of the appetite suppressant phentermine and the anti-seizure drug topiramate.
Advisers to the London-based EMA indicated last month they would recommend against approval of the medicine, and Vivus sank the most in seven months.
The European Commission usually adopts the committee’s advice, though it isn’t required to do so.
Vivus rose (VVUS) 2.1 percent to $20.60 at the close of New York trading. The shares have more than doubled this year.
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