News Summary: Regulators want more on Novo drugs

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Associated Press

Posted on February 11, 2013 at 12:00 PM

Updated Monday, Feb 11 at 1:01 PM

ANOTHER STUDY: Danish drugmaker Novo Nordisk said that U.S. regulators need to see data from a new study that evaluates cardiovascular health before they can finish reviewing the diabetes treatments Tresiba and Ryzodeg for approval.

THE CONSEQUENCE: Novo Nordisk submitted the drugs for U.S. approval in September 2011. Another study could delay a decision from the U.S. Food and Drug Administration for several years.

THE DRUGS: Tresiba and Ryzodeg both use the long-acting insulin degludec, which can help diabetics control their blood sugar levels beyond the 24-hour period offered by current products on the market. European regulators approved the drugs last month.

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