Feb 21 European health regulators for a second
time rejected a diet pill developed by Vivus Inc and
said the obesity treatment would not be approved there unless
the company conducts a large lengthy trial to prove its heart
safety, Vivus said on Thursday.
The drug, sold in the United States as Qsymia, was approved
by U.S. regulators last year. The U.S. Food and Drug
Administration also approved another diet pill, Belviq, sold by
Arena Pharmaceuticals Inc, making them the first new
obesity drugs approved in the United States in more than a
Qsymia, which was to be sold in Europe under the brand name
Qsiva, was initially rejected by the European Committee for
Medicinal Products for Human Use (CHMP) last October. Vivus
requested a re-examination of the decision and was turned down
again on Thursday.
"We are disappointed with the CHMP decision regarding Qsiva
and the position the Committee adopted with respect to the need
for a preapproval cardiovascular outcomes trial," Vivus
President Peter Tam said in a statement.
Another diet drug developed by Orexigen Therapeutics Inc
faces a similar hurdle in the United States after the
FDA said it would not approve its pill, which is called
Contrave, without a lengthy, expensive study to prove that it
does not increase the risk of heart attacks and strokes.
Vivus shares fell 2.4 percent to $12.57 in extended-hours
trading from their Nasdaq close at $12.88.