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 Japan.
"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 Monday.
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 Brandgaard.