European regulators reject Vivus obesity drug
(Reuters) - Vivus Inc said European regulators recommended that its obesity pill not be approved, citing potential safety concerns related to the long-term use of the drug.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) raised concerns over heart risks and birth defects and the drug Qsiva's use by patients for whom it was not indicated.
Vivus, which announced in late September that it was expecting a negative response, said it intends to appeal the panel opinion and request a re-examination of the decision by the CHMP.
The drug was launched in the United States in September under the brand name Qsymia, becoming the first new diet pill on the market in over a decade.
Vivus shares, which have fallen 11 percent since the September warning, were down 2 percent at $20.70 in extended trade. They closed at $21.06 on the Nasdaq on Thursday.
(Reporting by Balaji Sridharan in Bangalore, Editing by Anthony Kurian)
- Russia criticizes EU sanctions, raps U.S. over Ukraine role |
- Israel says ready to extend short Gaza truce; many bodies pulled from rubble |
- First Ebola victim in Sierra Leone capital on the run
- Apple iPhones allow extraction of deep personal data, researcher finds
- Amazon's far-reaching ambitions, lack of profits, unnerve investors |
Robert Blendon of the Harvard School of Public Health says the Affordable Care Act's unpopularity in 12 key states will keep it a central issue in the 2014 elections. Video