Novo Nordisk Injection Receives Backing from FDA Panel

A panel of Food and Drug Administration advisors has voted to approve the use of Novo Nordisk's diabetes drug Victoza for a new indication.

The panel voted 14-1 to approve the drug to be used in patients who are obese or dangerously overweight. Victoza, which belongs to a new class of medicines called GLP-1 agonist, received FDA approval in 2010 as a daily injection for type 2 diabetes.

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The current approval for treating obesity is being sought on the basis of a research, which found that 60 percent of patients taking Victoza for 12 months lost five percent of their body weight, and 31 percent of patients lost more than 10 percent.

These numbers compare favorably with patients in the same study, who took a placebo. Among the latter group, only 24 percent lost five percent of their body weight and nine percent lost more than 10 percent during 12 months of the study.

Danish company Novo Nordisk will now seek FDA approval for the drug. If approved, it will be marketed under the brand name Saxenda.

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Source-Medindia

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