U.S. drugmaker Vivus Inc. (NASDAQ: VVUS) announced this morning that the company had been notified that its anti-obesity drug, Qsiva, is not likely to be approved for use in the European Union. The company expects a ruling following the October meeting of the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).
In its announcement the company’s president said:
We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe. We will work closely with the CHMP to address the Committee’s concerns. VIVUS is committed to making this important medication available to obese patients in Europe.
The drug has been approved in the United States, where the company markets it under the trade name Qsymia. Vivus expected the drug to be blockbuster for the company and is not likely to give up easily if the October decision goes against the drug.
Shares are getting hammered this morning, down 12.5% at $20.75 in the premarket. The stock’s 52-week range is $7.47 to $31.21.