European regulators will likely reject Vivus‘ (NASDAQ:VVUS) new anti-obesity drug, the company announced. The news sent Vivus shares tumbling more than 11% in early Friday trading.
The drug — called Qsiva in Europe – received the okay from the U.S. Food and Drug Administration back in July and has launched in the U.S. under the name Qsymia, Reuters noted.
The Committee for Medicinal Products, part of the European Medicines Agency, must approve the drug for sale in Europe. However, Visus says that, based on feedback it has received, it believes the committee will recommend against giving the company permission to market the drug there.
The committee will not issue a formal decision until it convenes next month. If the committee does reject the drug, Vivus said it will review their comments and either appeal the decision, or start the approval process all over again.
In the U.S., Qsymia became the second anti-obesity drug approved by the FDA in more than a decade. In June, the agency approved Belviq, an obesity treatment from Arena Pharmaceutical (NASDAQ:ARNA).
Obtaining FDA approval for anti-obesity drugs has proven difficult in the wake of health concerns linked to other weight-control drugs. Both Qsymia and Belviq had to clear a number of safety questions and other regulatory hurdles before receiving permission for marketing in the U.S.