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Novo gets FDA letter on once-weekly liraglutide

Thu Dec 11, 2008 9:19am EST

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COPENHAGEN, Dec 11 (Reuters) - Danish drugmaker Novo Nordisk (NOVOb.CO) said on Thursday it had received a letter from U.S. regulators regarding its once-weekly version of liraglutide, setting out future requirements for extra cardiovascular studies.

The letter from the Food and Drug Administration relates to Novo's experimental product NN9535, which is currently in Phase II clinical trials, and contains general requirements, a spokesman said.

Novo Nordisk said there was nothing surprising in the FDA move and it would take the new requirements into account when planning Phase III tests.

The U.S. drugs watchdog recently sent similar letters to other drugmakers with diabetes drugs in early-stage development, saying it wanted more evidence on cardiovascular risk.

Novo Nordisk has not received such a letter regarding the once-daily version of liraglutide, which is now pending approval in both the United States and Europe. Lars Sorensen, Novo's chief executive, told Reuters last week he did not expect such requirements to be applied to the once-daily version before its approval. (Reporting by Karin Jensen and Ben Hirschler)



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