FDA defers Novo Nordisk's diabetes drug


NEW YORK The Food and Drug Administration has deferred giving Danish drug maker Novo Nordisk formal feedback on a long-awaited drug until fourth quarter 2009, Novo Nordisk announced.

The company said, however, that it would continue “constructive dialog” with the FDA regarding the regulatory process for liraglutide, a once-daily treatment for diabetes.

Novo Nordisk said it expected to provide an update on the regulatory process for the drug when it announces financial results for the first three quarters of 2009, on Oct. 29, if it does not get formal feedback by then, though the company said the news does not change its expectations for its financial results for 2009.

In other news, Novo Nordisk announced the opening of a new research center in Seattle, where it will seek to develop drugs for treating chronic inflammatory diseases. The company currently has four drugs in early clinical development for rheumatoid arthritis, psoriatic arthritis and lupus.

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