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Novo hopes for US FDA talks on Tresiba this week
February 11, 2013 / 9:30 AM / 5 years ago

Novo hopes for US FDA talks on Tresiba this week

COPENHAGEN, Feb 11 (Reuters) - Denmark’s Novo Nordisk hopes to talks with the U.S. authorities this week about a request for more heart risk tests on its new long-acting insulin Tresiba and how long they might take.

“I hope that we can start a dialogue with them this week,” Chief Scientific Officer Mads Thomsen told Reuters.

“We do not have an exact timing right now, but can put a timing on (the length of studies) when we have spoken to the FDA,” Thomsen said.

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.

Thomsen said the group would not be able to provide the data requested by the FDA either this year or in 2014.

“It is not realistic to provide any data this year or next year, it takes time to start up and recruit patients,” Thomsen said.

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