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Novo’s Insulin Degludec Receives FDA Advisory Committee Backing

by Kathy Jones on November 9, 2012 at 7:01 PM
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 Novo’s Insulin Degludec Receives FDA Advisory Committee Backing

An advisory committee to the US Food and Drug Administration has recommended the approval of an ultra-long-acting insulin degludec for type 1 and type 2 diabetes. The product has been developed by Danish drug maker Novo Nordisk.

The committee voted 8-4 in favor of approval while it was unanimous in recommending that a large scale trial should be conducted by the company to ascertain the cardiovascular risks posed by the drug.

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The committee members said that while they are a bit concerned over the high incidence of cardiovascular problems associated with drug compared to others in 16 different studies, the long lasting action of the drug meant that it can allow patients to take the drug at other times even if they miss it during their usual time.

"Currently available basal insulins are imperfect and don't last 24 hours. A true basal that gives constant coverage for 24 hours would make a difference", Johns Hopkins University School of Medicine's Dr David Cooke, who was the member of the panel, said.


Source: Medindia
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