COPENHAGEN Feb 10 Denmark's Novo Nordisk
said a request from U.S. authorities to conduct
additional clinical tests on its new long-acting insulin Tresiba
would have no impact on its plans for the drug in Europe and
"No. There will be no impact on the pricing. There will be
no impact on our plans ... neither in Europe nor in Japan,"
Chief Executive Lars Rebien said at an investor briefing on
Novo, the world's biggest insulin maker, said on Sunday the
U.S. Food and Drug Administration (FDA) had requested additional
data from a dedicated cardiovascular outcomes trial before it
would consider approving Tresiba and related product Ryzodeg.
The delayed launch of the drugs in the U.S. market would
make it more difficult for Novo to achieve its financial long
term targets, it said.
"We now have a significant delay in the potential U.S.
launch of Tresiba that will of course, everything else being
equal, make the achievement of the long-term financial targets a
bit more challenging," said Chief Financial Officer Jesper