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FDA Panel To Weigh Relevance Of Liraglutide’s Diabetes Experience In Obesity

 
• By Sue Sutter

Agency will ask external advisors Sept. 11 how the GLP-1 agonist’s safety in type 2 diabetes, approved as Victoza in 2010, informs the safety profile in obesity, where Novo Nordisk is seeking a higher dose and a different name.

FDA is seeking the Endocrinologic and Metabolic Drugs Advisory Committee’s input on the extent to which the safety of Novo Nordisk AS’ liraglutide can be extrapolated from its approval in type 2 diabetes to a new use in obesity.

In particular, FDA seeks the panel’s views on allowing liraglutide to be used in the first-line setting for weight management and whether an ongoing cardiovascular outcomes trial in diabetes would be sufficient to

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